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MGB Alert® JCV Probe Mix ASR - 48 Reactions

FDA UDI

Class I (US FDA UDI)

by ELITechGroup MDX LLC.

Identity

Trade Name
MGB Alert® JCV Probe 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 Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the VP2 Tantigen region of JC Virus. The mix consists of one probe at 0.72 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6- carboxyfluorescein and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm." FDA UDI
Model / Reference
M800602 FDA UDI
Description
"MGB Alert® JC Virus Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the VP2 Tantigen region of JC Virus. The mix consists of one probe at 0.72 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6- carboxyfluorescein and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm." FDA UDI

Identifiers

Catalog Number
M800602 FDA UDI
Primary DI / UDI-DI
03661540950360 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 Probe 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 b4015e0a-fd39-41c7-b1d9-65b60a7aaf3d 36 fields · synced May 30, 2026