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MGB Alert HSV1 Primer Mix, 48 rxn ASR, Finished Product

FDA UDI

Class I (US FDA UDI)

by ELITechGroup MDX LLC.

Identity

Trade Name
MGB Alert HSV1 Primer Mix, 48 rxn ASR, Finished Product FDA UDI
Generic Name
Herpes simplex virus 1 (HSV1) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
MGB Alert HSV-1 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the glycoprotein-D gene of HSV-1. The mix consists of a total of 9.0 nmol of primers per vial in a 1X TE buffer solution. The primers target a 90 bp region of the glycoprotein-D gene of HSV-1. FDA UDI
Model / Reference
M800585 FDA UDI
Description
MGB Alert HSV-1 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the glycoprotein-D gene of HSV-1. The mix consists of a total of 9.0 nmol of primers per vial in a 1X TE buffer solution. The primers target a 90 bp region of the glycoprotein-D gene of HSV-1. FDA UDI

Identifiers

Catalog Number
M800585 FDA UDI
Primary DI / UDI-DI
03661540952005 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Herpes simplex virus 1 (HSV1) 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: Herpes simplex virus 1 (HSV1) nucleic acid IVD, kit, nucleic acid technique (NAT)

MGB Alert HSV1 Primer Mix, 48 rxn ASR, Finished Product by ELITechGroup MDX LLC. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Herpes simplex virus 1 (HSV1) 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 b38d91a4-a962-40b6-8ee8-3a3c4eb5bd70 36 fields · synced Jun 1, 2026