Data / Medical devices / United States / Bio-Rad Laboratories, Inc.

Bio-Rad Laboratories, Inc.: FDA-registered device maker in Woodinville, WA, United States, 17 510(k) clearances and 3 PMA approvals

Name: Bio-Rad Laboratories, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bio-Rad Laboratories, Inc. is registered with the FDA (registration 3032705) in Woodinville, WA, United States. It lists 39 device types. The FDA files 17 510(k) clearances and 3 PMA approvals under its listings, the newest dated May 31, 2007. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3032705
FEI number: 3002701146
Address: 14620 NE North Woodinville Way, Woodinville, WA, United States, 98072
Owner or operator: BIO-RAD LABORATORIES, INC. (3022521)
Roles: Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer
First device listed: January 8, 2008
Registered through: 2026
Brand names listed: BIOPLEX 2200 ANA SCREEN RE, BIOPLEX 2200 ANA SCREEN RE Detector Calibration Pack, BIOPLEX 2200 ANA SCREEN RE Detector Cleaning Pack, BioPlex 220 Celiac IgG kit, BioPlex 2200 25-OH Vitamin D Calibrator Set, BioPlex 2200 25-OH Vitamin D Control Set, BioPlex 2200 25-OH Vitamin D Kit, BioPlex 2200 25-OH Vitamin D Reagent Pack and more

Devices it lists

Device	Product code	Class	Role	Source
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	NHX	2	Contract manufacturer	accessdata.fda.gov
Antibodies, Gliadin	MST	2	Contract manufacturer	accessdata.fda.gov
Antibody Igm, If, Epstein-Barr Virus	LJN	1	Contract manufacturer, Specification developer	accessdata.fda.gov
Antibody Igm,If, Cytomegalovirus Virus	LKQ	2	Contract manufacturer	accessdata.fda.gov
Antigens, Nontreponemal, All	GMQ	2	Contract manufacturer	accessdata.fda.gov
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control	DBM	2	Manufacturer	accessdata.fda.gov
Antinuclear Antibody, Antigen, Control	LKJ	2	Contract manufacturer	accessdata.fda.gov
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	DHN	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Autoantibodies, Endomysial(Tissue Transglutaminase)	MVM	2	Contract manufacturer	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Contract manufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Contract manufacturer	accessdata.fda.gov
Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)	MVJ	2	Contract manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	LFZ	2	Contract manufacturer, Specification developer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific	LGC	2	Specification developer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Mumps Virus	LJY	1	Contract manufacturer, Specification developer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Rubella	LFX	2	Specification developer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Rubeola Igg	LJB	1	Contract manufacturer, Specification developer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	LGD	2	Contract manufacturer, Specification developer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster	LFY	2	Contract manufacturer, Manufacturer for export, Specification developer	accessdata.fda.gov
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	LIP	2	Contract manufacturer	accessdata.fda.gov
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1	MXJ	2	Contract manufacturer	accessdata.fda.gov
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2	MYF	2	Contract manufacturer	accessdata.fda.gov
Epstein-Barr Virus, Other	LSE	1	Contract manufacturer, Manufacturer for export, Specification developer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Contract manufacturer	accessdata.fda.gov
Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv	OMI	2	Contract manufacturer	accessdata.fda.gov
Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm	PUQ	2	Contract manufacturer	accessdata.fda.gov
Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus	OPL	2	Contract manufacturer	accessdata.fda.gov
Pneumocystis Carinii	LYF	2	Manufacturer	accessdata.fda.gov
Qualitative And Quantitative Hepatitis B Virus Antibody Assays	SEI	2	Manufacturer	accessdata.fda.gov
Reagent, Borrelia Serological Reagent	LSR	2	Contract manufacturer, Specification developer	accessdata.fda.gov
Reagents, Antibody, Legionella, Direct & Indirect Fluorescent	LHL	2	Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Contract manufacturer	accessdata.fda.gov
System, Test, Anticardiolipin Immunological	MID	2	Contract manufacturer	accessdata.fda.gov
System, Test, Infectious Mononucleosis	KTN	2	Contract manufacturer	accessdata.fda.gov
System, Test, Vitamin D	MRG	2	Contract manufacturer	accessdata.fda.gov
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	MSV	2	Contract manufacturer	accessdata.fda.gov
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	MOB	2	Contract manufacturer	accessdata.fda.gov
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	LOM	2	Manufacturer	accessdata.fda.gov
Test, Hiv Detection	MZF	2	Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 16, 2004	K033915	MODIFICATION TO SERAQUEST EB VCA IGG	LSE	Substantially Equivalent	Quest Intl., Inc.	accessdata.fda.gov
January 15, 2004	K033780	MODIFICATION TO SERAQUEST VCA IGM	LJN	Substantially Equivalent	Quest Intl., Inc.	accessdata.fda.gov
November 2, 1999	K991975	SERAQUEST EB NA IGG	LSE	Substantially Equivalent	Quest Intl., Inc.	accessdata.fda.gov
January 13, 1999	K982485	SERAQUEST CMV IGM	LFZ	Substantially Equivalent	Quest Intl., Inc.	accessdata.fda.gov
October 16, 1998	K982281	SERAQUEST RUBELLA IGM	LFX	Substantially Equivalent	Quest Intl., Inc.	accessdata.fda.gov
April 23, 1998	K980059	SERAQUEST MUMPS IGG	LJY	Substantially Equivalent	Quest Intl., Inc.	accessdata.fda.gov
November 5, 1997	K972295	SERAQUEST VZV IGG	LFY	Substantially Equivalent	Quest Intl., Inc.	accessdata.fda.gov
January 22, 1997	K963282	SERAQUEST HSV IGG	LGC	Substantially Equivalent	Quest Intl., Inc.	accessdata.fda.gov
September 4, 1996	K961053	SERAQUEST RUBELLA IGG	LFX	Substantially Equivalent	Quest Intl., Inc.	accessdata.fda.gov
June 17, 1996	K960092	SERAQUEST TOXOPLASMA IGG	LGD	Substantially Equivalent	Quest Intl., Inc.	accessdata.fda.gov
February 23, 1996	K954191	SERAQUEST CMV IGG	LFZ	Substantially Equivalent	Quest Intl., Inc.	accessdata.fda.gov
December 20, 1991	K911590	IMMUNOWELL BORRELIA (LYME)TEST	LSR	Substantially Equivalent	General Biometrics, Inc.	accessdata.fda.gov
March 21, 1989	K890768	PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT	LYF	Substantially Equivalent	Genetic Systems Corp.	accessdata.fda.gov
August 22, 1985	K852237	LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT	LHL	Substantially Equivalent	Genetic Systems Corp.	accessdata.fda.gov
January 18, 1982	K813592	QUANTAFLUOR FLUORESCENT TEST REAGENTS	DHN	Substantially Equivalent	Kallestad Laboratories, Inc.	accessdata.fda.gov
April 14, 1981	K810863	KALLESTAD HEP-2 CELL LINE SUBSTRATE	DBM	Substantially Equivalent	Kallestad Laboratories, Inc.	accessdata.fda.gov
September 7, 1978	K780899	FLUORESCENT ANTI-NATIVE DNA TEST	DHN	Substantially Equivalent	Kallestad Laboratories, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
May 31, 2007	P060034	BIO RAD MONOLISA ANTI-HBC IGM EIA	SEI	7	March 19, 2014	accessdata.fda.gov
April 27, 2007	P060031	BIO-RAD MONOLISA ANTI-HBC EIA	SEI	7	December 12, 2013	accessdata.fda.gov
August 25, 2006	P050048	MONOLISA ANTI-HBS EIA	SEI	9	April 18, 2025	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 30, 2025	97106	Class II	Ongoing	Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human se	Due to a risk of false positive results that could lead to unnecessary medical treatment.	accessdata.fda.gov

Compare with other makers

Updated September 4, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.