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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 3 of 4

Device	Model / Reference	Registries	Class	Status
HLA-C SSP Kit	826212	FDA UDI	U	Unknown
IH-Card Anti-D (DVI+)	813251100	FDA UDI	N/A	Active
IH-Com V5.0	5.0.10	FDA UDI	Class II	Active
ABDR SSPtray	826230	FDA UDI	U	Unknown
IH-Card RhD(DVI-)+Phenotype	813290100	FDA UDI	N/A	Active
Anti-Human-Globulin, Anti-IgG, -C3d; polyspecific	804115100	FDA UDI	N/A	Active
Seraclone® Anti-C (RH2)	802280100	FDA UDI	N/A	Active
IH-Card ABD(DVI+)-Conf	813190100	FDA UDI	N/A	Active
TANGO infinity	850000010	FDA UDI	Class II	Active
IH-Incubator L	009303	FDA UDI	Class II	Active
Mlb 2	805200100	FDA UDI	Class II	Active
IH-Card AHG Anti-IgG	813420100	FDA UDI	N/A	Active
IH-Card Rh-Phenotype+K	813201100	FDA UDI	N/A	Active
Lymphotype HLA-AB 72 AN	823023	FDA UDI	U	Unknown
IH-Com	04.0.27	FDA UDI	Class II	Active
Seraclone Control AB0+Rh	805171100	FDA UDI	Class II	Active
Seraclone® Anti-k (KEL2)	808125100	FDA UDI	N/A	Unknown
IH-Card Anti-C-E-K	813272100	FDA UDI	N/A	Active
IH-Card RhD(DVI-)+Phenotype	813292100	FDA UDI	N/A	Active
IH-Card Anti-D (DVI-)	813262100	FDA UDI	N/A	Active
Biotestcell®-I 11 Plus	816022100	FDA UDI	N/A	Active
Erytype S RhD Confirm	806190100	FDA UDI	N/A	Active
Alsevers Solution	806510100	FDA UDI	Class II	Active
Biotestcell® A1 & B	816057100	FDA UDI	N/A	Active
Bromelin for Erytype	806210100	FDA UDI	Class II	Active
IH-Card ABO/RhD(DVI+)	813130100	FDA UDI	N/A	Active
Ih-500	001510	FDA UDI	Class II	Active
IH-Card ABD(DVI-)-Conf	813181100	FDA UDI	N/A	Active
IH-Card Anti-c	813230100	FDA UDI	N/A	Active
Biotestcell®-I 11	816021100	FDA UDI	N/A	Active
IH-Card Group A, B	813142100	FDA UDI	N/A	Active
Anti-Human Globulin Anti-IgG Solidscreen II	806516100	FDA UDI	N/A	Active
IH-Card Anti-e	813241100	FDA UDI	N/A	Active
IH-Anti D (RH1) Blend	813804100	FDA UDI	N/A	Active
IH-Card ABD(DVI-)-Conf	813182100	FDA UDI	N/A	Active
IH-Card ABO/D(DVI+)+Rev A1, B	813120100	FDA UDI	N/A	Active
Seraclone® Anti-Lea (LE1)	808403100	FDA UDI	N/A	Active
Seraclone® Anti-D (RH1)	802042100	FDA UDI	N/A	Active
IH-Card Neutral	813612100	FDA UDI	Class II	Active
IH-Papain	813540100	FDA UDI	Class II	Active
IH-Card Anti-C-E-K	813271100	FDA UDI	N/A	Active
Seraclone® Anti-K (KEL1)	808090100	FDA UDI	N/A	Active
IH-Reader 24	001200	FDA UDI	Class II	Active
Lymphoscreen DR 30x2	823350	FDA UDI	U	Unknown
IH-Card ABO/D(DVI-)+Rev A1, B	813112100	FDA UDI	N/A	Active
Seraclone® Anti-e (RH5)	802370100	FDA UDI	N/A	Active
IH-Titration Solution	813560100	FDA UDI	Class II	Active
IH-Card Anti-E	813221100	FDA UDI	N/A	Active
Lymphostabil	824020	FDA UDI	Class I	Unknown
Biotestcell® Pool	816065100	FDA UDI	N/A	Active

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