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DSQ Alert HT Primer Mix ASR

FDA UDI

Class I (US FDA UDI)

by ELITechGroup MDX LLC.

Identity

Trade Name
DSQ Alert HT Primer Mix ASR FDA UDI
Generic Name
Hepatitis D virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
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. FDA UDI
Model / Reference
M800811 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
m800811 FDA UDI
Primary DI / UDI-DI
03661540952807 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Hepatitis D 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

No

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 D virus nucleic acid IVD, kit, nucleic acid technique (NAT)

DSQ Alert HT 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 D 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 f2845f02-f171-4cd1-8d5c-76e9fec9f9bc 36 fields · synced May 30, 2026