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DSQ Alert™ HT HAV Primer Mix ASR

FDA UDI

Class I (US FDA UDI)

by ELITechGroup MDX LLC.

Identity

Trade Name
DSQ Alert™ HT HAV Primer Mix ASR FDA UDI
Generic Name
Hepatitis A virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
Product Description DSQ 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 Requirements 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. FDA UDI
Model / Reference
M800815 FDA UDI
Description
Product Description DSQ 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 Requirements 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. FDA UDI

Identifiers

Catalog Number
M800815 FDA UDI
Primary DI / UDI-DI
03661540952883 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Hepatitis A virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hepatitis A virus nucleic acid IVD, kit, nucleic acid technique (NAT)

DSQ Alert™ HT HAV Primer Mix ASR by ELITechGroup MDX LLC. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hepatitis A virus nucleic acid IVD, kit, nucleic acid technique (NAT).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ELITechGroup MDX LLC.

Sources (1)

  • FDA UDI 4d81287c-2548-41f2-ba17-75cf9bd42204 36 fields · synced Jun 6, 2026