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MGB Alert HSV-2 Probe Mix ASR, 09N45-002

FDA UDI

Class I (US FDA UDI)

by ELITechGroup MDX LLC.

Identity

Trade Name
MGB Alert HSV-2 Probe Mix ASR, 09N45-002 FDA UDI
Generic Name
Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control FDA UDI
Device Name
MGB Alert® HSV 1 & 2 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from HSV 1 and 2 (Herpes Simplex Virus 1 and 2). The mix consists of one probe at 0.2 nmol per vial in a 1X TE buffer solution. The probe dye is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. FDA UDI
Model / Reference
M800588-am FDA UDI
Description
MGB Alert® HSV 1 & 2 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from HSV 1 and 2 (Herpes Simplex Virus 1 and 2). The mix consists of one probe at 0.2 nmol per vial in a 1X TE buffer solution. The probe dye is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. FDA UDI

Identifiers

Catalog Number
M800588-am FDA UDI
Primary DI / UDI-DI
03661540950094 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control 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 & 2 (HSV1 & 2) nucleic acid IVD, control

MGB Alert HSV-2 Probe Mix ASR, 09N45-002 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 & 2 (HSV1 & 2) nucleic acid IVD, control.

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 a9583153-4c60-4696-8d00-b4468adb8bd0 36 fields · synced May 30, 2026