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MGB Alert Enterovirus v.2.0 Probe Mix ASR , 48 rxns

FDA UDI

Class I (US FDA UDI)

by ELITechGroup MDX LLC.

Identity

Trade Name
MGB Alert Enterovirus v.2.0 Probe Mix ASR , 48 rxns FDA UDI
Generic Name
Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
DSQ Alert Enterovirus v2.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the 5’-untranslated region (5’-UTR) of the enterovirus RNA genome. The mix consists of a total of 0.8 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is labeled with the 6-FAM fluorophore and has an excitation wavelength maximum of 496 nm and an emission wavelength maximum of 517 nm. FDA UDI
Model / Reference
M800709 FDA UDI
Description
DSQ Alert Enterovirus v2.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the 5’-untranslated region (5’-UTR) of the enterovirus RNA genome. The mix consists of a total of 0.8 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is labeled with the 6-FAM fluorophore and has an excitation wavelength maximum of 496 nm and an emission wavelength maximum of 517 nm. FDA UDI

Identifiers

Catalog Number
M800709 FDA UDI
Primary DI / UDI-DI
03661540952111 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Enterovirus nucleic acid (serotypes 68-71) 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: Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT)

MGB Alert Enterovirus v.2.0 Probe Mix ASR , 48 rxns by ELITechGroup MDX LLC. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Enterovirus nucleic acid (serotypes 68-71) 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 b76f9a14-3ddc-4df3-9045-1da669cbbf5d 36 fields · synced May 30, 2026