← Back to catalogue

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

FDA UDI

Class I (US FDA UDI)

by ELITechGroup MDX LLC.

Identity

Trade Name
MGB Alert Enterovirus v.2.0 Primer 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 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the 5’ untranslated region (5’-UTR) of the enterovirus RNA genome. The mix consists of a total of 14.0 nmol of primers per vial in a 1X TE buffer solution. The primers target a 138 bp region of the 5’-UTR of enterovirus. FDA UDI
Model / Reference
M800708 FDA UDI
Description
DSQ Alert Enterovirus v2.0 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the 5’ untranslated region (5’-UTR) of the enterovirus RNA genome. The mix consists of a total of 14.0 nmol of primers per vial in a 1X TE buffer solution. The primers target a 138 bp region of the 5’-UTR of enterovirus. FDA UDI

Identifiers

Catalog Number
M800708 FDA UDI
Primary DI / UDI-DI
03661540952104 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 Primer 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
ELITechGroup MDX LLC.

Sources (1)

  • FDA UDI f432daef-3f84-4104-8b0d-55078f2fa6b7 36 fields · synced May 31, 2026