DSQ Alert HHV7 Probe Mix ASR M800767

GUDID 03661540952739

Product Description DSQ 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 Requirements The 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 Precautions Carefully 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

Human herpesvirus 7 (HHV7) nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID03661540952739
NIH Device Record Key0f58ed35-dac7-4ba5-8fb6-6f38036de682
Commercial Distribution StatusIn Commercial Distribution
Brand NameDSQ Alert HHV7 Probe Mix ASR
Version Model NumberM800767
Catalog NumberM800767
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

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
GS103661540952739 [Primary]

FDA Product Code

MVUReagents, Specific, Analyte

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2026-01-13
Device Publish Date2025-10-14

Devices Manufactured by Elitechgroup Mdx LLC

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 ASR2026-01-13Product Description DSQ 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 Requirements The 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 Precautions Carefully 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.
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
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