Identity
- Trade Name
- ALBAcyte A2 Cells FDA UDI
- Generic Name
- Group A2 Rh (D) negative reagent red blood cell IVD, antigen FDA UDI
- Device Name
- 2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte A2 Cells, for tube techniques. FDA UDI
- Model / Reference
- Z406U FDA UDI
- Description
- 2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte A2 Cells, for tube techniques. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060242471131 FDA UDI
- GMDN Term
- Group A2 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 A2 Rh (D) negative reagent red blood cell IVD, antigen
ALBAcyte A2 Cells by Alba Bioscience Limited — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Group A2 Rh (D) negative reagent red blood cell IVD, antigen.
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 7707bac2-c1fc-49ec-b366-ce819aca4c8f 34 fields · synced May 30, 2026