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MGB Alert® HHV8 Primer Mix ASR - 48 Reactions

FDA UDI

Class I (US FDA UDI)

by ELITechGroup MDX LLC.

Identity

Trade Name
MGB Alert® HHV8 Primer Mix ASR - 48 Reactions FDA UDI
Generic Name
Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
"MGB Alert® HHV8 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HHV8. The mix consists of a total of 8.1 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 109 bp nucleic acid sequence from the ORF26 gene region in HHV8." FDA UDI
Model / Reference
M800597 FDA UDI
Description
"MGB Alert® HHV8 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HHV8. The mix consists of a total of 8.1 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 109 bp nucleic acid sequence from the ORF26 gene region in HHV8." FDA UDI

Identifiers

Catalog Number
M800597 FDA UDI
Primary DI / UDI-DI
03661540950285 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Human herpesvirus 8 (HHV8) 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: Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT)

MGB Alert® HHV8 Primer Mix ASR - 48 Reactions by ELITechGroup MDX LLC. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Human herpesvirus 8 (HHV8) 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 4ba3fbee-422e-47ba-a8ce-de9ecdc5838f 36 fields · synced Jun 8, 2026