Identity
- Trade Name
- ALBAclone Anti-D fusion FDA UDI
- Generic Name
- Anti-Rh(D) red blood cell grouping IVD, antibody FDA UDI
- Device Name
- This Anti-D reagent is for the in vitro detection and identification of human RhD blood group status in patient and donor samples by direct agglutination and the indirect antiglobulin test. FDA UDI
- Model / Reference
- Z043U FDA UDI
- Description
- This Anti-D reagent is for the in vitro detection and identification of human RhD blood group status in patient and donor samples by direct agglutination and the indirect antiglobulin test. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060242471797 FDA UDI
- GMDN Term
- Anti-Rh(D) red blood cell grouping IVD, antibody 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
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: Anti-Rh(D) red blood cell grouping IVD, antibody
ALBAclone Anti-D fusion by Alba Bioscience Limited — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anti-Rh(D) red blood cell grouping IVD, antibody.
- Beckman Coulter® PK® Systems Anti-D (PK1) (P3X61) — DIAGAST
- Anti-D (Monoclonal Blend) Series 5 — IMMUCOR, INC.
- ORTHO — Ortho-Clinical Diagnostics
- Anti-D (RH1) IgM+IgG — DIAGAST
- Anti-D (RH1) IgM — DIAGAST
- Anti-D (Monoclonal Blend) Gamma-clone — IMMUCOR, INC.
- IH-Anti D (RH1) Blend — Bio-Rad Medical Diagnostics GmbH
- IH-Card Anti-D (DVI-) — Bio-Rad Medical Diagnostics GmbH
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 97c6faf4-9e3f-47a5-8016-5e4797ed1ea9 34 fields · synced May 31, 2026