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DSQ Alert® HT JCV Primer Mix ASR

FDA UDI

Class I (US FDA UDI)

by ELITechGroup MDX LLC.

Identity

Trade Name
DSQ Alert® HT JCV Primer Mix ASR FDA UDI
Generic Name
JC virus (JCV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
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 FDA UDI
Model / Reference
M800813 FDA UDI
Description
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 FDA UDI

Identifiers

Catalog Number
M800813 FDA UDI
Primary DI / UDI-DI
03661540952821 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
JC virus (JCV) 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: JC virus (JCV) nucleic acid IVD, kit, nucleic acid technique (NAT)

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

Similar devices

Also classified as JC virus (JCV) 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 0c450984-7f36-42bd-9bd7-7a388e96075c 36 fields · synced May 31, 2026