Identity
- Trade Name
- ALBAsera Anti-s FDA UDI
- Generic Name
- Anti-S [MNS004] red blood cell grouping IVD, antibody FDA UDI
- Device Name
- Blood Grouping Reagent, ALBAsera Anti-s (Polyclonal) for indirect antiglobulin test by tube technique. FDA UDI
- Model / Reference
- Z186U FDA UDI
- Description
- Blood Grouping Reagent, ALBAsera Anti-s (Polyclonal) for indirect antiglobulin test by tube technique. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060242471018 FDA UDI
- GMDN Term
- Anti-S [MNS004] red blood cell grouping IVD, antibody FDA UDI
Classification
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ALBAsera Anti-s by Alba Bioscience Limited — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | N/A | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alba Bioscience Limited
Sources (2)
- FDA UDI 29e149e5-c366-4e98-80bd-0f5573670621 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026