← Back to catalogue
ALBAcyte Expanded Rh Negative Antibody Screen
FDA UDIIdentity
- Trade Name
- ALBAcyte Expanded Rh Negative Antibody Screen FDA UDI
- Generic Name
- Antibody identification panel reagent red blood cell IVD, kit, agglutination FDA UDI
- Device Name
- Reagent Red Blood Cells, ALBAcyte Expanded Rh Negative Antibody Screen for tube techniques, 2-3% suspension. FDA UDI
- Model / Reference
- Z464U FDA UDI
- Description
- Reagent Red Blood Cells, ALBAcyte Expanded Rh Negative Antibody Screen for tube techniques, 2-3% suspension. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060242471377 FDA UDI
- GMDN Term
- Antibody identification panel reagent red blood cell IVD, kit, agglutination 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: Antibody identification panel reagent red blood cell IVD, kit, agglutination
ALBAcyte Expanded Rh Negative Antibody Screen by Alba Bioscience Limited — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Antibody identification panel reagent red blood cell IVD, kit, agglutination.
- Biotestcell®-I 11 — Bio-Rad Medical Diagnostics GmbH
- Panocell-20 — IMMUCOR, INC.
- RESOLVE — Ortho-Clinical Diagnostics
- IH-Panel 11 Papain — Bio-Rad Medical Diagnostics GmbH
- Data-Cyte Plus 0.8% — Medion Grifols Diagnostics AG
- RESOLVE — Ortho-Clinical Diagnostics
- Data-Cyte Extend 0.8% — Medion Grifols Diagnostics AG
- Data-Cyte Plus P 0.8% — Medion Grifols Diagnostics AG
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alba Bioscience Limited
Sources (1)
- FDA UDI fc24aab9-c9c6-45d2-b156-86f06ddafc6a 34 fields · synced May 30, 2026