Identity
- Trade Name
- ALBAcyte A1 Cells FDA UDI
- Generic Name
- Group A1 Rh (D) negative reagent red blood cell IVD, antigen FDA UDI
- Device Name
- 2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte A1 Cells, for tube technique. FDA UDI
- Model / Reference
- Z401U FDA UDI
- Description
- 2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte A1 Cells, for tube technique. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060242471124 FDA UDI
- GMDN Term
- Group A1 Rh (D) negative reagent red blood cell IVD, antigen FDA UDI
Classification
- Commercial Distribution
- 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
Yes
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
Category: Group A1 Rh (D) negative reagent red blood cell IVD, antigen
ALBAcyte A1 Cells by Alba Bioscience Limited — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Alba Bioscience Limited
Sources (1)
- FDA UDI c2efeacc-5827-41b9-abe4-03309c6a3861 34 fields · synced Jun 8, 2026