BIO-RAD LABORATORIES, INC.

FDA Device Registration & Listing · Woodinville, WA, US · Registration 3032705

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3032705
FEI Number
3002701146
Entity Name
BIO-RAD LABORATORIES, INC.
City/State/Country
Woodinville, WA, US
Establishment Address
14620 NE North Woodinville Way, Woodinville, WA 98072, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
BIO-RAD LABORATORIES, INC. (Owner Number: 3022521)
Owner / Operator Contact Address
8415 216th St SE, --, Woodinville, WA 98072, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K982485
PMA Number
N/A

All Registered Proprietary Names

SERAQUEST VZV IGG BioPlex2200 Celiac IgG Calibrator Set BioPlex 2200 Celiac IgA Calibrator set BioPlex 2200 Celiac IgG Calibrator Set BioPlex2200 Celiac IgA Control Set BioPlex 220 Celiac IgG kit BioPlex2200 Celiac IgA Calibrator Set BioPlex 2200 Celiac IgG Control Set BioPlex 2200 Celiac IgA kit BioPlex2200 Celiac IgA Reagent Pack BioPlex 2200 Celiac IgA Control Set BioPlex2200 Celiac IgG Control Set BioPlex2200 Celiac IgG Reagent Pack SERAQUEST VCA IGM SERAQUEST RUBELLA IGM BioPlex 2200 MMRV IgG BioPlex 2200 MMV IgM Control Set BioPlex 2200 MMV IgM Reagent Pack BioPlex 2200 MMV IgM Calibrator Set BioPlex 2200 anti-CCP Control Set BioPlex2200 Anti-CCP Calibrator Set BioPlex 2200 anti-CCP Calibrator Set BioPlex2200 Anti-CCP Reagent Pack BioPlex2200 Anti-CCP Control Set BioPlex 2200 anti-CCP Reagent Pack BioPlex2200 ToRC IgG Reagent Pack BioPlex 2200 ToRC IgG BioPlex2200 ToRC IgG Calibrator Set BioPlex2200 ToRC IgG Control Set BioPlex2200 Multi-Analyte Detection System BIOPLEX 2200 ANA SCREEN RE BIOPLEX 2200 ANA SCREEN RE Detector Cleaning Pack BIOPLEX 2200 ANA SCREEN RE Detector Calibration Pack BioPlex 2200 HSV-1 & HSV-2 BioPlex 2200 HSV-1 & HSV-2 IgG Calibrator Set BioPlex 2200 HSV-1 and HSV-2 IgG Kit BioPlex 2200 HSV-1 & HSV-2 IgG Control Set BioPlex 2200 HIV Ag-Ab Control Set BioPlex 2200 HIV Ag-Ab Calibrator Set BioPlex 2200 HIV Ag-Ab Reagent Pack MONOLISA Anti-HBc EIA MONOLISA Anti-HBc IgM EIA MONOFLUO Legionella IFA Kallestad Crithidia (nDNA) Kallestad Crithidia (nDNA) 8-well Kit, 48 tests Kallestad Crithidia Slide, 8-Well, 6/PK Kallestad Crithidia Slide, 8-Well, 20/PK Kallestad Crithidia (nDNA) 4-well Kit, 24 tests Kallestad HEp-2 Slide, 12-Well, 20/PK Kallestad Positive nDNA Pattern Control Kallestad HEp-2 Slide, 24-Well, 8/PK Kallestad HEp-2 12-well Kit, 240 tests Kallestad FITC Conjugate Kallestad HEp-2 Slide, 12-Well, 100/PK Kallestad Universal Conjugate, 100 ml Kallestad mounting Medium Kallestad HEp-2 Evans Blue Counterstain Kallestad HEp-2 Patient Sample Diluent, 100 mL Kallestad Hep-2, 6-well Kit, 48 tests Kallestad FITC Conjugate, 100 mL Kallestad HEp-2 12-well Kit, 60 tests Kallestad Counterstain MONOFLUO Pneumocystis jirovecii IFA Monofluo Pneumocystis IFA BioPlex 2200 25-OH Vitamin D Reagent Pack BioPlex 2200 25-OH Vitamin D Control Set BioPlex 2200 25-OH Vitamin D Calibrator Set SERAQUEST HSV IGG BioPlex 2200 ToRC IgM MONOLISA Anti-HBs Calibrator Kit, MONOLISA Anti-HBs EIA BioPlex 2200 25-OH Vitamin D Control Set BioPlex 2200 25-OH Vitamin D Kit BioPlex 2200 25-OH Vitamin D Calibrator Set BioPlex2200 EBV IgG Calibrator Set BioPlex2200 EBV IgG Control Set BioPlex 2200 Syphilis Total and RPR BioPlex 2200 Syphilis Total & RPR Calibrator BioPlex 2200 Syphilis Total & RPR Control Kallestad Mouse Stomach Kidney Slide, 8-Well, 100/PK Kallestad Mouse Stomach Kidney Slide, 8-Well, 6/PK Kallestad Mouse Stomach Kidney Slide, 8-Well, 20/PK Kallestad Mouse Stomach Kidney, 8-well Kit, 48 tests Kallestad Mouse Stomach Kidney SERAQUEST TOXOPLASMA IGG GS HIV Combo Ag/Ab EIA GS HIV Combo Ag/Ab EIA, 960 tests SERAQUEST RUBELLA IGG SERAQUEST MUMPS IGG BioPlex 2200 EBV IgG BioPlex2200 APLS IgA Control Set BioPlex2200 APLS IgA Reagent Pack BioPlex2200 APLS IgA Calibrator Set BioPlex2200 APLS IgG Reagent Pack BioPlex2200 APLS IgG Calibrator Set BioPlex2200 APLS IgG Control Set BioPlex2200 APLS IgM Reagent Pack BioPlex2200 APLS IgM Calibrator Set BioPlex2200 APLS IgM Control Set SERAQUEST CMV IGG SERAQUEST CMV IGM

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster Microbiology Class 2 866.3900 2016-04-14
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2014-02-25
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2014-02-25
MVM Autoantibodies, Endomysial(Tissue Transglutaminase) Immunology Class 2 866.5660 2014-02-25
MST Antibodies, Gliadin Immunology Class 2 866.5750 2014-02-25
LJN Antibody Igm, If, Epstein-Barr Virus Microbiology Class 1 866.3235 2016-04-14
LFX Enzyme Linked Immunoabsorbent Assay, Rubella Microbiology Class 2 866.3510 2016-04-14
OPL Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus Microbiology Class 2 866.3510 2014-06-23
LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster Microbiology Class 2 866.3900 2014-06-23
LJB Enzyme Linked Immunoabsorbent Assay, Rubeola Igg Microbiology Class 1 866.3520 2014-06-23
LJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus Microbiology Class 1 866.3380 2014-06-23
LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster Microbiology Class 2 866.3900 2016-09-27
NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) Immunology Class 2 866.5775 2013-01-31
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2014-06-23
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2014-06-23
OMI Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv Microbiology Class 2 866.3510 2014-06-23
LKJ Antinuclear Antibody, Antigen, Control Immunology Class 2 866.5100 2014-06-23
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2014-06-23
MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 Microbiology Class 2 866.3305 2014-06-23
MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 Microbiology Class 2 866.3305 2014-06-23
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2014-06-23
MZF Test, Hiv Detection Microbiology Class 2 866.3956 2015-08-17
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2010-11-02
SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays Microbiology Class 2 866.3173 2010-11-02
SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays Microbiology Class 2 866.3173 2010-11-02
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2010-11-02
LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent Microbiology Class 2 866.3300 2018-11-13
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5100 2008-07-08
DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5090 2008-07-08
LYF Pneumocystis Carinii Microbiology Class 2 866.3780 2008-07-08
MRG System, Test, Vitamin D Clinical Chemistry Class 2 862.1825 2015-01-14
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2015-01-14
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2015-01-14
LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific Microbiology Class 2 866.3305 2016-04-14
PUQ Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm Microbiology Class 2 866.3510 2017-05-24
LKQ Antibody Igm,If, Cytomegalovirus Virus Microbiology Class 2 866.3175 2017-05-24
LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus Microbiology Class 2 866.3175 2017-05-24
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2017-05-24
LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Microbiology Class 2 866.3780 2017-05-24
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-05-24
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2008-03-13
SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays Microbiology Class 2 866.3173 2008-03-13
MRG System, Test, Vitamin D Clinical Chemistry Class 2 862.1825 2018-07-24
LSE Epstein-Barr Virus, Other Microbiology Class 1 866.3235 2015-08-25
LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum Microbiology Class 2 866.3830 2017-05-24
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-05-24
GMQ Antigens, Nontreponemal, All Microbiology Class 2 866.3820 2017-05-24
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2017-05-24
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5100 2008-07-08
LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Microbiology Class 2 866.3780 2016-04-14
MZF Test, Hiv Detection Microbiology Class 2 866.3956 2011-08-25
LFX Enzyme Linked Immunoabsorbent Assay, Rubella Microbiology Class 2 866.3510 2016-04-14
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5100 2013-03-19
LJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus Microbiology Class 1 866.3380 2016-04-14
LSE Epstein-Barr Virus, Other Microbiology Class 1 866.3235 2014-06-23
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2014-06-23
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2014-06-23
LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum Microbiology Class 2 866.3830 2014-06-23
MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) Immunology Class 2 866.5660 2013-02-27
MID System, Test, Anticardiolipin Immunological Immunology Class 2 866.5660 2013-02-27
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2013-02-27
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2013-02-27
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2014-02-25
MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) Immunology Class 2 866.5660 2014-02-25
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2014-02-25
MID System, Test, Anticardiolipin Immunological Immunology Class 2 866.5660 2014-02-25
LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus Microbiology Class 2 866.3175 2016-04-14
LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus Microbiology Class 2 866.3175 2016-04-14

Official Correspondent

David Bhend

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIO-RAD LABORATORIES, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007886270 BIO-RAD LABORATORIES, INC. Woodinville, WA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24
K981278 Roche Diagnostics GmbH ELECSYS CALCHECK CA 125II 1998-04-23
K143687 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material 2015-07-17
K143376 Siemens Healthcare Diagnostics, Inc. ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material 2014-12-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0164-2015 Siemens Healthcare Diagnostics, Inc 2
Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Z-0081-2017 Siemens Healthcare Diagnostics, Inc. 2
SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age.
Z-0082-2017 Siemens Healthcare Diagnostics, Inc. 2
SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age
Z-0003-2007 N/A 2
Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032705. Last updated year: 2026. Please use registration number 3032705 when referencing this establishment in official correspondence.
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