Identity
- Trade Name
- MedMira Universal Buffer FDA UDI
- Generic Name
- HIV1 antibody IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- The package contains replacement component for use only with Reveal G3 Rapid HIV-1 Antibody Test. The component is lot-specific. FDA UDI
- Model / Reference
- 1009785RDB-G3 FDA UDI
- Description
- The package contains replacement component for use only with Reveal G3 Rapid HIV-1 Antibody Test. The component is lot-specific. FDA UDI
Identifiers
- Catalog Number
- 1009785RDB-G3 FDA UDI
- Primary DI / UDI-DI
- 00628451188049 FDA UDI
- FDA Product Code
- MZF FDA UDI
- GMDN Term
- HIV1 antibody IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3956 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MedMira Universal Buffer by MedMira Laboratories Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- MedMira Laboratories Inc
Sources (1)
- FDA UDI 550ff804-d1c7-4314-b825-a2be92af0b32 36 fields · synced Jun 7, 2026