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ORTHOTM Sera Anti-D (DVI) Blood Grouping Reagent
FDA UDIIdentity
- Trade Name
- ORTHOTM Sera Anti-D (DVI) Blood Grouping Reagent FDA UDI
- Generic Name
- Partial (variant) Rh(D) category VI red blood cell grouping IVD, antibody FDA UDI
- Device Name
- The Anti-D (Monoclonal) reagent (Anti-RH1) is for the qualitative in vitro detection of human RhD positive red blood cells by the direct agglutination test. This Anti-D reagent will detect D category DVI cells. The Anti-D (Monoclonal) reagent (Anti-RH1) is indicated for the determination of the RhD status for donors and neonates born to Rh negative women for RhIG therapy assessment. This Anti-D (Monoclonal) reagent (Anti-RH1) is not indicated for pre-transfusion testing of patients as the reagent detects partial RhD (DVI) by direct agglutination. FDA UDI
- Model / Reference
- 6904624 FDA UDI
- Description
- The Anti-D (Monoclonal) reagent (Anti-RH1) is for the qualitative in vitro detection of human RhD positive red blood cells by the direct agglutination test. This Anti-D reagent will detect D category DVI cells. The Anti-D (Monoclonal) reagent (Anti-RH1) is indicated for the determination of the RhD status for donors and neonates born to Rh negative women for RhIG therapy assessment. This Anti-D (Monoclonal) reagent (Anti-RH1) is not indicated for pre-transfusion testing of patients as the reagent detects partial RhD (DVI) by direct agglutination. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10758750030323 FDA UDI
- GMDN Term
- Partial (variant) Rh(D) category VI 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
No
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: Partial (variant) Rh(D) category VI red blood cell grouping IVD, antibody
ORTHOTM Sera Anti-D (DVI) Blood Grouping Reagent 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 4030c839-e94e-4616-a528-be92d20e74bc 34 fields · synced Jun 1, 2026