Identity
- Trade Name
- SARS-CoV-2 ELITe MGB Assay FDA UDI
- Generic Name
- SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- SARS-CoV-2 ELITe MGB® Assay is a real-time RT-PCR test intended for the presumptive qualitative detection of nucleic acid from the SARS-CoV-2 in nasal, nasopharyngeal, and oropharyngeal swabs from individuals with signs and symptoms of infection who are suspected of COVID-19. FDA UDI
- Model / Reference
- M800703 FDA UDI
- Description
- SARS-CoV-2 ELITe MGB® Assay is a real-time RT-PCR test intended for the presumptive qualitative detection of nucleic acid from the SARS-CoV-2 in nasal, nasopharyngeal, and oropharyngeal swabs from individuals with signs and symptoms of infection who are suspected of COVID-19. FDA UDI
Identifiers
- Catalog Number
- M800703 FDA UDI
- Primary DI / UDI-DI
- 03661540952050 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- SARS-CoV-2 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: SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
SARS-CoV-2 ELITe MGB Assay by ELITechGroup MDX LLC. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ELITechGroup MDX LLC.
Sources (1)
- FDA UDI c257312e-b92e-4617-a9c3-e7d8553641f8 36 fields · synced May 30, 2026