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MGB Alert® JCV Primer Mix ASR - 48 Reactions

FDA UDI

Class I (US FDA UDI)

by ELITechGroup MDX LLC.

Identity

Trade Name
MGB Alert® JCV Primer Mix ASR - 48 Reactions FDA UDI
Generic Name
JC virus (JCV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
"MGB Alert® JC Virus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from JC Virus. The mix consists of a total of 6.48 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 78 bp nucleic acid sequence from the VP2 Tantigen region of JC Virus" FDA UDI
Model / Reference
M800601 FDA UDI
Description
"MGB Alert® JC Virus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from JC Virus. The mix consists of a total of 6.48 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 78 bp nucleic acid sequence from the VP2 Tantigen region of JC Virus" FDA UDI

Identifiers

Catalog Number
M800601 FDA UDI
Primary DI / UDI-DI
03661540950346 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

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: JC virus (JCV) nucleic acid IVD, kit, nucleic acid technique (NAT)

MGB Alert® JCV 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 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 94f1c1a9-3f75-468b-a89b-310e25fc76ff 36 fields · synced May 30, 2026