ELITechGroup MDX LLC.

Matched from indexed company URL: Elitechgroup Mdx LLC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3003540236	3003540236	ELITechGroup MDX LLC.	1	Y	2026-01-01	21720 23rd Dr SE, Suite 150 Bothell WA US 98021

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
03661540952739	DSQ Alert HHV7 Probe Mix ASR - Product DescriptionDSQ Alert® HHV-7 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the major capsid protein gene of HHV-7. The mix consists of a total of 0.64 nmol of HHV-7 probe per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The probe is labeled with the FAM fluorophore and has an excitation wavelength maximum of 495 nm and an emission wavelength maximum of 517 nm. Each product lot will go through functional testing with an approved test method.Storage and Handling RequirementsThe reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than -10 degrees Celsius when received. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.Warnings and PrecautionsCarefully read this entire package insert.- The operator must be trained to perform high complexity work and avoid distractions that may lead to errors.- Use general precautions and wear appropriate personal protective equipment when handling the reagents.- Do not eat, drink, or smoke in designated work areas.- Wash hands thoroughly after handling reagents.- Prevent reagent carryover by working in a nuclease-free area keeping one tube open at a time during reagent preparation and PCR setup. Completed PCR tubes or sealed plates should not be opened.- Dispose of all material that has come into contact with specimens and reagents in accordance with applicable national, international, and regional regulations.	1-833-227-3400	mdx@elitechgroup.com
03661540953118	DSQ Alert Measles Primer Mix ASR, 48 rxn - Product DescriptionDSQ Alert® Measles Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the N-nucleoprotein gene of Measles. The mix consists of a total of 4.0 nmol of primers per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The primers target a 148 bp region of the N-nucleoprotein gene of Measles. Each product lot will go through functional testing with an approved test method.Storage and Handling RequirementsThe reagent contained in this package shall be shipped on dry ice, be protected from light and stored less than -10°C when received. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.Warnings and PrecautionsCarefully read this entire package insert.- The operator must be trained to perform high complexity work and avoid distractions which may lead to errors.- Use general precautions and wear appropriate personal protective equipment when handling the reagents.- Do not eat, drink, or smoke in designated work areas.- Wash hands thoroughly after handling reagents.- Prevent reagent carryover by working in a nuclease-free area keeping one tube open at a time during reagent preparation and PCR setup. Completed PCR tubes or sealed plates should not be opened.- Dispose of all material that has come into contact with specimens and reagents in accordance with applicable national, international, and regional regulations.	1-833-227-3400	mdx@elitechgroup.com
03661540953125	DSQ Alert Measles Probe Mix ASR, 48 rxn - Product DescriptionDSQ Alert® Measles Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the N-nucleoprotein gene of Measles The mix consists of a total of 1.28 nmol of Measles probe per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. One probe is a FAM labeled fluorophore and has an excitation wavelength maximum of 495 nm and an emission wavelength maximum of 520 nm. A second probe is an AP593 labeled fluorophore that has an excitation wavelength maximum of 593 nm and an emission wavelength maximum of 613 nm. Each product lot will go through functional testing with an approved test method.Storage and Handling RequirementsThe reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than -10°C when received. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.Warnings and PrecautionsCarefully read this entire package insert.- The operator must be trained to perform high complexity work and avoid distractions which may lead to errors.- Use general precautions and wear appropriate personal protective equipment when handling the reagents.- Do not eat, drink, or smoke in designated work areas.- Wash hands thoroughly after handling reagents.- Prevent reagent carryover by working in a nuclease-free area keeping one tube open at a time during reagent preparation and PCR setup. Completed PCR tubes or sealed plates should not be opened.- Dispose of all material that has come into contact with specimens and reagents in accordance with applicable national, international, and regional regulations.	1-833-227-3400	mdx@elitechgroup.com
03661540953132	DSQ Alert RNase P Primer Mix ASR 48 rxn - Product DescriptionDSQ Alert® RNase P Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the human RNase P gene. The mix consists of a total of 0.3 nmol of primers per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The primers target a 65 bp region of the human RNase P gene. Each product lot will go through functional testing with an approved test method.Storage and Handling RequirementsThe reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than -10°C when received. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.Warnings and PrecautionsCarefully read this entire package insert.- The operator must be trained to perform high complexity work and avoid distractions which may lead to errors.- Use general precautions and wear appropriate personal protective equipment when handling the reagents.- Do not eat, drink, or smoke in designated work areas.- Wash hands thoroughly after handling reagents.- Prevent reagent carryover by working in a nuclease-free area keeping one tube open at a time during reagent preparation and PCR setup. Completed PCR tubes or sealed plates should not be opened.- Dispose of all material that has come into contact with specimens and reagents in accordance with applicable national, international, and regional regulations.	1-833-227-3400	mdx@elitechgroup.com

elitechgroup.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
108982	1764419289	K180559	HSV 1 & 2 ELITe MGB Kit; ELITe InGenius	PGI	2018-10-29
108982	1536595845	K132468	MRSA/SA ELITE MGB, ELITE MGB SOFTWARE	NQX	2013-10-17
108982	1175636932	K112937	MRSA/SA ELITE MGB	NQX	2012-06-01
108982	1397365503	K083430	REAL-TIME PCR INTERNAL CONTROL 2B SET	OLD	2009-01-15
108982	2031134576
108982	1743020633
108982	1915549129
108982	1946864853

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
NQX	2	2013-10-17
PGI	1	2018-10-29
OLD	1	2009-01-15

GUDID#

DSQ Alert® HT Pneumocystis jirovecii Primer Mix - Product DescriptionDSQ Alert® HT Pneumocystis jirovecii Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the large subunit ribosomal RNA gene of Pneumocystis jirovecii. The mix consists of a total of 100 nmol of primers per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The primers target a 144 bp region of the large subunit ribosomal RNA gene of Pneumocystis jirovecii. Each product lot will go through functional testing with an approved test method.Storage and Handling RequirementsThe reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less or equal to -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.Warnings and PrecautionsCarefully read this entire package insert.- The operator must be trained to perform high complexity work and avoid distractions which may lead to errors.- Use general precautions and wear appropriate personal protective equipment when handling the reagents.- Do not eat, drink, or smoke in designated work areas.- Wash hands thoroughly after handling reagents.- Prevent reagent carryover by working in a nuclease-free area keeping one tube open at a time during reagent preparation and PCR setup. Completed PCR tubes or sealed plates should not be opened.- Dispose of all material that has come into contact with specimens and reagents in accordance with applicable national, international, and regional regulations

Elitechgroup Mdx LLC

2026-05-12

DSQ Alert® HT Pneumocystis jirovecii Probe Mix - Product DescriptionDSQ Alert® HT Pneumocystis jirovecii Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the large subunit ribosomal RNA gene of Pneumocystis jirovecii The mix consists of a total of 24.5 nmol of DSQ probe per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The probe is labeled with the FAM fluorophore and has an excitation wavelength maximum of 495 nm and an emission wavelength maximum of 521 nm. Each product lot will go through functional testing with an approved test method.Storage and Handling RequirementsThe reagent contained in this package should be protected from light and stored at less or equal to -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.Warnings and PrecautionsCarefully read this entire package insert.- The operator must be trained to perform high complexity work and avoid distractions which may lead to errors.- Use general precautions and wear appropriate personal protective equipment when handling the reagents.- Do not eat, drink, or smoke in designated work areas.- Wash hands thoroughly after handling reagents.- Prevent reagent carryover by working in a nuclease-free area keeping one tube open at a time during reagent preparation and PCR setup. Completed PCR tubes or sealed plates should not be opened.- Dispose of all material that has come into contact with specimens and reagents in accordance with applicable national, international, and regional regulations.

Elitechgroup Mdx LLC

2026-05-12

DSQ Alert Measles Primer Mix ASR, 48 rxn - Product DescriptionDSQ Alert® Measles Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the N-nucleoprotein gene of Measles. The mix consists of a total of 4.0 nmol of primers per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The primers target a 148 bp region of the N-nucleoprotein gene of Measles. Each product lot will go through functional testing with an approved test method.Storage and Handling RequirementsThe reagent contained in this package shall be shipped on dry ice, be protected from light and stored less than -10°C when received. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.Warnings and PrecautionsCarefully read this entire package insert.- The operator must be trained to perform high complexity work and avoid distractions which may lead to errors.- Use general precautions and wear appropriate personal protective equipment when handling the reagents.- Do not eat, drink, or smoke in designated work areas.- Wash hands thoroughly after handling reagents.- Prevent reagent carryover by working in a nuclease-free area keeping one tube open at a time during reagent preparation and PCR setup. Completed PCR tubes or sealed plates should not be opened.- Dispose of all material that has come into contact with specimens and reagents in accordance with applicable national, international, and regional regulations.

Elitechgroup Mdx LLC

2026-03-24

DSQ Alert Measles Probe Mix ASR, 48 rxn - Product DescriptionDSQ Alert® Measles Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the N-nucleoprotein gene of Measles The mix consists of a total of 1.28 nmol of Measles probe per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. One probe is a FAM labeled fluorophore and has an excitation wavelength maximum of 495 nm and an emission wavelength maximum of 520 nm. A second probe is an AP593 labeled fluorophore that has an excitation wavelength maximum of 593 nm and an emission wavelength maximum of 613 nm. Each product lot will go through functional testing with an approved test method.Storage and Handling RequirementsThe reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than -10°C when received. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.Warnings and PrecautionsCarefully read this entire package insert.- The operator must be trained to perform high complexity work and avoid distractions which may lead to errors.- Use general precautions and wear appropriate personal protective equipment when handling the reagents.- Do not eat, drink, or smoke in designated work areas.- Wash hands thoroughly after handling reagents.- Prevent reagent carryover by working in a nuclease-free area keeping one tube open at a time during reagent preparation and PCR setup. Completed PCR tubes or sealed plates should not be opened.- Dispose of all material that has come into contact with specimens and reagents in accordance with applicable national, international, and regional regulations.

Elitechgroup Mdx LLC

2026-03-24

DSQ Alert RNase P Primer Mix ASR 48 rxn - Product DescriptionDSQ Alert® RNase P Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the human RNase P gene. The mix consists of a total of 0.3 nmol of primers per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The primers target a 65 bp region of the human RNase P gene. Each product lot will go through functional testing with an approved test method.Storage and Handling RequirementsThe reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than -10°C when received. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.Warnings and PrecautionsCarefully read this entire package insert.- The operator must be trained to perform high complexity work and avoid distractions which may lead to errors.- Use general precautions and wear appropriate personal protective equipment when handling the reagents.- Do not eat, drink, or smoke in designated work areas.- Wash hands thoroughly after handling reagents.- Prevent reagent carryover by working in a nuclease-free area keeping one tube open at a time during reagent preparation and PCR setup. Completed PCR tubes or sealed plates should not be opened.- Dispose of all material that has come into contact with specimens and reagents in accordance with applicable national, international, and regional regulations.

Elitechgroup Mdx LLC

2026-03-24

DSQ Alert RNase P Probe Mix ASR 48 rxn - Product DescriptionDSQ Alert® RNase P Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the human RNase P gene. The mix consists of a total of 0.3 nmol of DSQ probe per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The probe is labeled with the AP525 fluorophore and has an excitation wavelength maximum of 527 nm and an emission wavelength maximum of 549 nm. Each product lot will go through functional testing with an approved test method.Storage and Handling RequirementsThe reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than -10°C when received. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.Warnings and PrecautionsCarefully read this entire package insert.- The operator must be trained to perform high complexity work and avoid distractions which may lead to errors.- Use general precautions and wear appropriate personal protective equipment when handling the reagents.- Do not eat, drink, or smoke in designated work areas.- Wash hands thoroughly after handling reagents.- Prevent reagent carryover by working in a nuclease-free area keeping one tube open at a time during reagent preparation and PCR setup. Completed PCR tubes or sealed plates should not be opened.- Dispose of all material that has come into contact with specimens and reagents in accordance with applicable national, international, and regional regulations.

Elitechgroup Mdx LLC

2026-03-24

DSQ Alert HHV7 Primer Mix ASR - Product DescriptionDSQ Alert® HHV-7 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the major capsid protein gene of HHV-7. The mix consists of a total of 3.2 nmol of primers per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The primers target a 106 bp region of the major capsid protein gene of HHV-7. Each product lot will go through functional testing with an approved test method.Storage and Handling RequirementsThe reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than 10 degrees Celsius when received. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.Warnings and PrecautionsCarefully read this entire package insert.- The operator must be trained to perform high complexity work and avoid distractions that may lead to errors.- Use general precautions and wear appropriate personal protective equipment when handling the reagents.- Do not eat, drink, or smoke in designated work areas.- Wash hands thoroughly after handling reagents.- Prevent reagent carryover by working in a nuclease-free area keeping one tube open at a time during reagent preparation and PCR setup. Completed PCR tubes or sealed plates should not be opened.- Dispose of all material that has come into contact with specimens and reagents in accordance with applicable national, international, and regional regulations.

Elitechgroup Mdx LLC

2025-10-14

DSQ Alert HHV7 Probe Mix ASR - Product DescriptionDSQ Alert® HHV-7 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the major capsid protein gene of HHV-7. The mix consists of a total of 0.64 nmol of HHV-7 probe per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The probe is labeled with the FAM fluorophore and has an excitation wavelength maximum of 495 nm and an emission wavelength maximum of 517 nm. Each product lot will go through functional testing with an approved test method.Storage and Handling RequirementsThe reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than -10 degrees Celsius when received. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.Warnings and PrecautionsCarefully read this entire package insert.- The operator must be trained to perform high complexity work and avoid distractions that may lead to errors.- Use general precautions and wear appropriate personal protective equipment when handling the reagents.- Do not eat, drink, or smoke in designated work areas.- Wash hands thoroughly after handling reagents.- Prevent reagent carryover by working in a nuclease-free area keeping one tube open at a time during reagent preparation and PCR setup. Completed PCR tubes or sealed plates should not be opened.- Dispose of all material that has come into contact with specimens and reagents in accordance with applicable national, international, and regional regulations.

Elitechgroup Mdx LLC

2025-10-14

MRSA/SA ELITe MGB - MRSA/SA ELITe MGB™ is a qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA purified from nasal swabs. MRSA/SA ELITe MGB™ is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections or to guide or monitor treatment for MRSA infections. A negative result does not preclude MRSA/SA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

Elitechgroup Mdx LLC

2016-10-13

MGB Alert Internal Control Set IC2-480 rxn - The MGB Alert Internal Control Set IC2 consists of reagents intended for use as an unassayed internal extraction and amplificationprocess control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2 can be used to detect systemicvariation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is notintended to monitor other real-time PCR processes.

Elitechgroup Mdx LLC

2020-09-15

MGB Alert®Internal Control 1C Set, 480 rxn - The MGB Alert Internal Control Set IC1-C consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC1-C can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes

Elitechgroup Mdx LLC

2020-09-15

MGB Alert HHV-6 Primer Mix ASR - 480 rxn - """MGB Alert® HHV-6 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HHV-6 (HumanHerpesvirus 6). The mix consists of a total of 24.8 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 115 nucleic acid sequencefrom the U67 gene region of HHV-6. """

Elitechgroup Mdx LLC

2020-09-14

MGB Alert® Chlamydophila Pneumoniae Probe Mix ASR - 48 Reactions - MGB Alert® Chlamydophila pneumoniae Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the Major Outer Membrane protein gene region of Chlamydophila pneumoniae. The mix consists of one probe at 0.72 nmol per vial in a 1X TE buffer solution. The probe is labeled with fluorescein (FAM) and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm.

Elitechgroup Mdx LLC

2020-09-08

MGB Alert® HDV Primer Mix ASR - Product DescriptionMGB Alert® HDV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the Hepatitis Delta Virus RNA. The mix consists of a total of 2.5 nmol of primers per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The primers target a 57 bp region of the Hepatitis Delta Virus RNA. Each product lot will go through functional testing with an approved test method.Storage and Handling RequirementsThe reagent contained in this package shall be shipped on dry ice, protected from light and stored at less than -10degrees Celsius when received. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.Warnings and PrecautionsCarefully read this entire package insert.- The operator must be trained to perform high complexity work and avoid distractions which may lead to errors.- Use general precautions and wear appropriate personal protective equipment when handling the reagents.- Do not eat, drink, or smoke in designated work areas.- Wash hands thoroughly after handling reagents.- Prevent reagent carryover by working in a nuclease-free area keeping one tube open at a time during reagent preparation and PCR setup. Completed PCR tubes or sealed plates should not be opened.- Dispose of all material that has come into contact with specimens and reagents in accordance with applicable national, international, and regional regulations.

Elitechgroup Mdx LLC

2025-10-15

MGB Alert HDV Probe Mix ASR - Product DescriptionMGB Alert® HDV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the Hepatitis Delta Virus RNA. The mix consists of a total of 0.6 nmol of Pleiades probe per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The probe is labeled with the FAM fluorophore and has an excitation wavelength maximum of 496 nm and an emission wavelength maximum of 517 nm. Each product lot will go through functional testing with an approved test method.Storage and Handling RequirementsThe reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than -10 degrees Celsius when received. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.Warnings and PrecautionsCarefully read this entire package insert.- The operator must be trained to perform high complexity work and avoid distractions which may lead to errors.- Use general precautions and wear appropriate personal protective equipment when handling the reagents.- Do not eat, drink, or smoke in designated work areas.- Wash hands thoroughly after handling reagents.- Prevent reagent carryover by working in a nuclease-free area keeping one tube open at a time during reagent preparation and PCR setup. Completed PCR tubes or sealed plates should not be opened.- Dispose of all material that has come into contact with specimens and reagents in accordance with applicable national, international, and regional regulations.

Elitechgroup Mdx LLC

2025-10-15

MGB Alert 2X ELITaq Master Mix, 48rxn - The MGB Alert ELITaq Master Mix is a premixed ready-to-use solution containing necessary components and reaction buffer for efficient amplification of DNA templates by PCR. The solution is supplied at 2X relative to the optimal final concentration in the PCR, and contains 2X reaction buffer, dNTPs, MgCl2, and DNA polymerase with 5’ - 3’ exonuclease activity. PCR grade water is also provided in the product.

Elitechgroup Mdx LLC

2023-02-03

MGB Alert ELITaq Master Mix, 480 rxn - The MGB Alert ELITaq Master Mix is a premixed ready-to-use solution containing necessary components and reaction buffer for efficient amplification of DNA templates by PCR. The solution is supplied at 2X relative to the optimal final concentration in the PCR, and contains 2X reaction buffer, dNTPs, MgCl2, and DNA polymerase with 5’ - 3’ exonuclease activity. PCR grade water is also provided in the product.

Elitechgroup Mdx LLC

2023-02-03

MGB Alert Platinum Master Mix-48 rxn - The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data.

Elitechgroup Mdx LLC

2020-09-15

MGB Alert 2X PCR Master Mix 480 rxn - The MGB Alert PCR Master Mix package includes ready to use 2x master mix containing a non-Taq thermostable enzyme lacking exonuclease activity and provided in antibody inactivated form. An initial high-temperature incubation step denatures the antibodies to activate the enzyme. The master mix also includes Uracil-DNA Glycosylase (UDG) and dUTP to prevent carry-over contamination. MGB Alert PCR Enhancer and MGB Alert 25 mM MgCl2 are provided for additional flexibility in optimizing reaction conditions.

Elitechgroup Mdx LLC

2020-09-15

MGB Alert One-Step Reverse Transcriptase PCR Master Mix - The MGB Alert One-Step Reverse Transcriptase PCR Master Mix package includes a 2X mastermix containing a thermostable polymerase with exonuclease activity and provided in hot-start format.Included are 100X reverse transcriptase, 50X RNase inhibitor, and RNase-free water in separatetubes.

Elitechgroup Mdx LLC

2020-09-15

MGB Alert 2X PCR Master Mix 48 rxn - The MGB Alert PCR Master Mix package includes ready to use 2x master mix containinga non-Taq thermostable enzyme lacking exonuclease activity and provided in antibodyinactivated form. An initial high-temperature incubation step denatures the antibodies toactivate the enzyme. The master mix also includes Uracil-DNA Glycosylase (UDG) anddUTP to prevent carry-over contamination. MGB Alert PCR Enhancer and MGB Alert 25 mMMgCl2 are provided for additional flexibility in optimizing reaction conditions.

Elitechgroup Mdx LLC

2020-09-15

MGB Alert Platinum Master Mix, 09N41-005 - The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data.

Elitechgroup Mdx LLC

2020-09-15

MGB Alert Platinum Master Mix-480rxn - The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data.

Elitechgroup Mdx LLC

2020-09-15

MGB Alert Platinum Master Mix, with water-48rxn - The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data.

Elitechgroup Mdx LLC

2020-09-15

MGB Alert Platinum Master Mix with water-480rxn - """The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays whichtarget DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates nodiagnostic information or data."""

Elitechgroup Mdx LLC

2020-09-15

MGB Alert PCR Master Mix 09N41-004 - The MGB Alert PCR Master Mix package includes ready to use 2x master mix containinga non-Taq thermostable enzyme lacking exonuclease activity and provided in antibodyinactivated form. An initial high-temperature incubation step denatures the antibodies toactivate the enzyme. The master mix also includes Uracil-DNA Glycosylase (UDG) anddUTP to prevent carry-over contamination. MGB Alert PCR Enhancer and MGB Alert 25 mMMgCl2 are provided for additional flexibility in optimizing reaction conditions.

Elitechgroup Mdx LLC

2020-09-14

DSQ Alert® HT JCV Primer Mix ASR - DSQ Alert® HT JCV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the gene A in large tumor antigen region of JC Virus (Human polyomavirus 2). The mix consists of a total of 39.2 nmol of primers per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The primers target a 78 bp region of the gene A of JCV. Each product lot will go through functional testing with an approved test method.The reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles

Elitechgroup Mdx LLC

2025-03-06

DSQ Alert® HT JCV Probe Mix ASR - Product DescriptionDSQ Alert® HT JCV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the gene A in large tumor antigen region of JC Virus (Human polyomavirus 2). The mix consists of a total of 3.9 nmol of DSQ probe per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The probe is labeled with the AP530 fluorophore and has an excitation wavelength maximum of 530 nm and an emission wavelength maximum of 550 nm. Each product lot will go through functional testing with an approved test method.Storage and Handling RequirementsThe reagent contained in this package should be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.

Elitechgroup Mdx LLC

2025-03-06

DSQ Alert HT Norovirus GI Primer Mix ASR - Product DescriptionDSQ Alert® HT Norovirus GI Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences in RNA-dependent RNA polymerase (RdRp) region of Norovirus Genogroup GI. The mix consists of a total of 41.6 nmol of primers per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The primers target a 92 bp amplicon of the RNA-dependent RNA polymerase (RdRp) region of Norovirus Genogroup GI. Each product lot will go through functional testing with an approved test method.Storage and Handling RequirementsThe reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.Warnings and PrecautionsCarefully read

Elitechgroup Mdx LLC

2025-03-06

DSQ Alert® HT Norovirus GI Probe Mix ASR - Product DescriptionDSQ Alert® HT Norovirus GI Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences in RNA-dependent RNA polymerase (RdRp) region of Norovirus Genogroup GI. The mix consists of a total of 8.3 nmol of DSQ probe per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The probe is labeled with the AP593 fluorophore and has an excitation wavelength maximum of 593 nm and an emission wavelength maximum of 613 nm. Each product lot will go through functional testing with an approved test method.Storage and Handling RequirementsThe reagent contained in this package should be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.

Elitechgroup Mdx LLC

2025-03-06

DSQ Alert HT Norovirus GII Primer Mix ASR - Product DescriptionDSQ Alert® HT Norovirus GII Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences in RNA-dependent RNA polymerase (RdRp) region of Norovirus Genogroup GII. The mix consists of a total of 41.6 nmol of primers per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The primers target a 92 bp amplicon of the RNA-dependent RNA polymerase (RdRp) region of Norovirus Genogroup GII. Each product lot will go through functional testing with an approved test method.Storage and Handling RequirementsThe reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.

Elitechgroup Mdx LLC

2025-03-06

DSQ Alert® HT Norovirus GII Probe Mix ASR - Product DescriptionDSQ Alert® HT Norovirus GII Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences in RNA-dependent RNA polymerase (RdRp) region of Noro virus Genogroup GII. The mix consists of a total of 8.3 nmol of DSQ probe per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The probe is labeled with the FAM fluorophore and has an excitation wavelength maximum of 496 nm and an emission wavelength maximum of 517 nm. Each product lot will go through functional testing with an approved test method.Storage and Handling RequirementsThe reagent contained in this package should be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.

Elitechgroup Mdx LLC

2025-03-06

DSQ Alert™ HT HAV Primer Mix ASR - Product DescriptionDSQ Alert® HT HAV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the 5’ UTR of HAV. The mix consists of a total of 23.4 nmol of primers per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The primers target a 90 bp region of the 5’ UTR of HAV. Each product lot will go through functional testing with an approved test method.Storage and Handling RequirementsThe reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.

Elitechgroup Mdx LLC

2025-03-06

DSQ Alert® HT HAV Probe Mix ASR - Product DescriptionDSQ Alert® HT HAV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the 5’ UTR of HAV. The mix consists of a total of 7.8 nmol of DSQ probe per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The probe is labeled with the AP530 fluorophore and has an excitation wavelength maximum of 530 nm and an emission wavelength maximum of 550 nm. Each product lot will go through functional testing with an approved test method.Storage and Handling RequirementsThe reagent contained in this package should be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.

Elitechgroup Mdx LLC

2025-03-06

DSQ Alert® BKV ASR v3.0 Probe Mix - DSQ Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids from the BKVirus.

Elitechgroup Mdx LLC

2024-12-20

DSQ Alert® Internal Control set IC1 - The DSQ Alert Internal Control Set IC1 contains the MGB Alert IC1 DNA Template, the DSQ Alert IC1 v3.0 Primers, and the MGB AlertIC1 Probe. When used as intended, the Internal Control Set IC1 DSQ will detect systemic variation that may arise during the nucleic acidextraction and amplification processes associated with real-time PCR assays.

Elitechgroup Mdx LLC

2024-10-24

DSQ Alert Internal Control set IC1 - The DSQ Alert Internal Control Set IC1 contains the MGB Alert IC1 DNA Template, the DSQ Alert IC1 v3.0 Primers, and the DSQ AlertIC1 Probe. When used as intended, the Internal Control Set IC1 DSQ will detect systemic variation that may arise during the nucleic acidextraction and amplification processes associated with real-time PCR assays.The reagent contained in this package should be protected from light and stored at less or equal to -10 degrees Celsius. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaws.

Elitechgroup Mdx LLC

2024-07-29

DSQ Alert HT Primer Mix ASR - DSQ Alert™ HT HDV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the Hepatitis Delta Virus RNA. The mix consists of a total of 31.2 nmol of primers per vial in a 1X TE buffer solution. The primers target a 57 bp region of the Hepatitis Delta Virus RNA.The reagent contained in this package should be protected from light and stored at less or equal to -10 degrees Celsius. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaws.

Elitechgroup Mdx LLC

2024-07-16

DSQ Alert HT Probe Mix ASR - DSQ Alert™ HT HDV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the Hepatitis Delta Virus RNA. The mix consists of a total of 7.8 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is labeled with the 6-FAM fluorophore and has an excitation wavelength maximum of 496 nm and an emission wavelength maximum of 517 nm. The reagent contained in this package should be protected from light and stored at less or equal to -10 degrees Celsius. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaws.

Elitechgroup Mdx LLC

2024-07-16

DSQ Alert BK Virus v3.0 Primer Mix - DSQ Alert BK Virus ASR v3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acids from the BK Virus. The mix consists of a total of 6.4 nmol of primers per vial in a 1X TE buffer solution. The primers target a 72 bp region of the major capsid protein VP1 gene of the BK Virus.The reagent contained in this package should be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.

Elitechgroup Mdx LLC

2024-05-15

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