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Bio-Rad Medical Diagnostics GmbH

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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 800-224-6723
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 312576506

Catalogue (168)

Page 2 of 4

Device	Model / Reference	Registries	Class	Status
Washing Solution Concentrate	848000091	FDA UDI	Class II	Active
Alsevers Solution	806510100	FDA UDI	Class II	Active
IH-Panel Plus 6	814090100	FDA UDI	N/A	Active
IH-Card ABO/D(DVI+)+Rev A1, B	813121100	FDA UDI	N/A	Active
Seraclone® Anti-Jkb (JK2)	808184100	FDA UDI	N/A	Active
IH-Panel 11 Papain	814080100	FDA UDI	N/A	Active
Solidscreen II-Control	806514100	FDA UDI	Class II	Active
Lymphotype HLA-AB 120 special	823031	FDA UDI	U	Unknown
IH-Card ABO/RhD(DVI+)	813131100	FDA UDI	N/A	Active
Mlb 2	805205100	FDA UDI	Class II	Active
Mlb 2	805200100	FDA UDI	Class II	Active
IH-Card Anti-c	813231100	FDA UDI	N/A	Active
IH-Card Anti-e	813242100	FDA UDI	N/A	Active
IH-Card Rh-Phenotype+K	813200100	FDA UDI	N/A	Active
Lymphotype HLA-DR/DQ 72	823102	FDA UDI	Class II	Unknown
Seraclone® Anti-S (MNS3)	808052100	FDA UDI	N/A	Active
Erytype® S Rh Donor	806190100	FDA UDI	N/A	Active
Ih-1000	001100	FDA UDI	Class II	Active
Erytype S Rh+K Type	806195100	FDA UDI	N/A	Active
Control-HLA (pos.)	824101	FDA UDI	U	Unknown
IH-Card ABD(DVI+)-Conf	813191100	FDA UDI	N/A	Active
IH-Card Rh-Phenotype+K	813202100	FDA UDI	N/A	Active
IH-Card ABO/D(DVI+)+Rev A1, B	813122100	FDA UDI	N/A	Active
Control-HLA (neg.)	824106	FDA UDI	U	Unknown
Seraclone® Anti-Jka (JK1)	808179100	FDA UDI	N/A	Active
Lymphotype HLA-ABC 72	823020	FDA UDI	U	Unknown
IH-Card AHG Anti-IgG, -C3d	813412100	FDA UDI	N/A	Active
ABC SSPtray	826240	FDA UDI	U	Unknown
IH-Card Anti-K	813281100	FDA UDI	N/A	Active
Lymphoscreen ABC-60	823300	FDA UDI	U	Unknown
HLA-A SSP Kit	826201	FDA UDI	U	Unknown
IH-AbID	12010902	FDA UDI	Class II	Active
Lymphoflot	824012	FDA UDI	Class I	Unknown
IH-Card Neutral	813611100	FDA UDI	Class II	Active
Lymphotype HLA-AB 144	823070	FDA UDI	U	Unknown
IH-Card Control	813600100	FDA UDI	Class II	Active
IH-Card Anti-e	813240100	FDA UDI	N/A	Active
IH-Card Group A, B	813141100	FDA UDI	N/A	Active
Seraclone® Anti-c (RH4)	802346100	FDA UDI	N/A	Active
DRB SSP Kit	826215	FDA UDI	U	Unknown
Seraclone® Anti-Fya (JK1)	808188100	FDA UDI	N/A	Active
IH-Card Anti-K	813282100	FDA UDI	N/A	Active
IH-Card Anti-E	813220100	FDA UDI	N/A	Active
Seraclone® Anti-A, B (ABO3)	801375100	FDA UDI	N/A	Active
IH-Card Anti-D (DVI+)	813250100	FDA UDI	N/A	Active
Lymphoscreen ABC-60	823300	FDA UDI	U	Unknown
IH-Cell Pool	814060100	FDA UDI	N/A	Active
Solidscreen II Strip	806521100	FDA UDI	Class II	Active
IH-Card AHG Anti-IgG, -C3d	813411100	FDA UDI	N/A	Active
IH-Card Anti-C	813212100	FDA UDI	N/A	Active

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