Identity
- Trade Name
- Genedrive(R) 96 SARS CoV2 kit FDA UDI
- Generic Name
- SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Low profile 96 well PCR plated assay and optical film for use on Biorad CFX96 instrument. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Low profile 96 well PCR plated assay and optical film for use on Biorad CFX96 instrument. FDA UDI
Identifiers
- Catalog Number
- ID-CoV2-01-BPU FDA UDI
- Primary DI / UDI-DI
- 05060654860103 FDA UDI
- FDA Product Code
- QLT FDA UDI
- GMDN Term
- SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- N FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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)
Genedrive(R) 96 SARS CoV2 kit by Genedrive Diagnostics Ltd — Class N — 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 N | Pending data |
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Manufacturer
- Manufacturer
- Genedrive Diagnostics Ltd
Sources (1)
- FDA UDI 1b57f101-c7db-4a68-a4d9-70cd51999b14 36 fields · synced May 29, 2026