DSQ Alert Measles Probe Mix ASR, 48 rxn M800846

GUDID 03661540953125

Product Description DSQ 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 Requirements The 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 Precautions Carefully 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

Measles virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID03661540953125
NIH Device Record Key5db5534c-1cc6-4b68-afac-2d2d362d617c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDSQ Alert Measles Probe Mix ASR, 48 rxn
Version Model NumberM800846
Catalog NumberM800846
Company DUNS117458512
Company NameElitechgroup Mdx LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -30 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540953125 [Primary]

FDA Product Code

MVUReagents, Specific, Analyte

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-04-01
Device Publish Date2026-03-24

Devices Manufactured by Elitechgroup Mdx LLC

03661540953118 - DSQ Alert Measles Primer Mix ASR, 48 rxn2026-04-01 Product Description DSQ Alert® Measles Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligo
03661540953125 - DSQ Alert Measles Probe Mix ASR, 48 rxn2026-04-01Product Description DSQ 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 Requirements The 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 Precautions Carefully 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.
03661540953125 - DSQ Alert Measles Probe Mix ASR, 48 rxn2026-04-01 Product Description DSQ Alert® Measles Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA olig
03661540953132 - DSQ Alert RNase P Primer Mix ASR 48 rxn2026-04-01 Product Description DSQ Alert® RNase P Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligo
03661540953163 - DSQ Alert RNase P Probe Mix ASR 48 rxn2026-04-01 Product Description DSQ Alert® RNase P Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA olig
03661540952722 - DSQ Alert HHV7 Primer Mix ASR2026-01-13 Product Description DSQ Alert® HHV-7 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonu
03661540952739 - DSQ Alert HHV7 Probe Mix ASR2026-01-13 Product Description DSQ Alert® HHV-7 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligon
03661540952821 - DSQ Alert® HT JCV Primer Mix ASR2025-03-14 DSQ Alert® HT JCV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed
03661540952838 - DSQ Alert® HT JCV Probe Mix ASR2025-03-14 Product Description DSQ Alert® HT JCV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligo

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.