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Sign in to claim this brandBio-Rad Medical Diagnostics GmbH
US
Last updated May 30, 2026
Part of Bio-Rad Medical Diagnostics Gmbh
What Bio-Rad Medical Diagnostics GmbH makes
Bio-Rad Medical Diagnostics GmbH produces in vitro diagnostic (IVD) reagents and kits for blood grouping and antibody identification, including agglutination-based ABO/Rh typing, Rh/Kell phenotype testing, and antibody screening. Their portfolio includes red blood cell grouping antibodies (e.g., Anti-Rh(D), Anti-AB, Anti-E), immunohaematology reagents like Low Ionic-Strength Salt Solution (LISS), and antibody identification panels. Additional products cover quality control (QC) solutions, neutralisation reagents, and specific antibody controls for transfusion compatibility testing.
The company’s devices are classified under FDA’s Class I (general controls) and Class II (special controls) categories, with listings in the FDA’s Unique Device Identifier (UDI) database. Their products are intended for use in blood banks and transfusion medicine to ensure compatibility and safety in transfusion procedures.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- bio-rad.com
- —
- —
- [email protected]
- Phone
- 800-224-6723
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 312576506
Catalogue (168)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| IH-Cell I-II | 814050100 | FDA UDI | N/A | Active |
| IH-Cell I-II-III | 814030100 | FDA UDI | N/A | Active |
| Solidscreen II Anti-D (RH1) Blend | 806530100 | FDA UDI | N/A | Active |
| IH-LISS Rack | 813510100 | FDA UDI | Class II | Active |
| Wash Solution A Concentrate | 12012668 | FDA UDI | Class I | Active |
| Biotestcell®-I 8 | 816020100 | FDA UDI | N/A | Active |
| Solidscreen II-Control B | 806519100 | FDA UDI | Class II | Active |
| Lymphotype HLA-ABC 120 | 823030 | FDA UDI | U | Unknown |
| IH-Cell A1 & B | 814010100 | FDA UDI | N/A | Active |
| Coombscell-E | 816030100 | FDA UDI | Class II | Active |
| IH-Card Neutral | 813610100 | FDA UDI | Class II | Active |
| Lymphotype HLA-B27 special | 823110 | FDA UDI | U | Unknown |
| Seraclone® Anti-B (ABO2) | 801350100 | FDA UDI | N/A | Active |
| IH-Card Group A, B | 813140100 | FDA UDI | N/A | Active |
| IH-Card Anti-K | 813280100 | FDA UDI | N/A | Active |
| Seraclone® Anti-D (RH1) Blend | 802033100 | FDA UDI | N/A | Active |
| IH-Card ABD(DVI-)-Conf | 813180100 | FDA UDI | N/A | Active |
| Lymphotype HLA-ABC 144 Italia | 823045 | FDA UDI | U | Unknown |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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