FDA Registration
Active
🇺🇸 United States
Bio-Rad Laboratories, Inc.
Reg #: 2915274
·
FEI: 2915274
·
Expires 2026
Products
73
Proprietary Names
119
Establishment Types
5
Classifications
73
Registration Details
- Registration Name
- Bio-Rad Laboratories, Inc.
- Registration Number
- 2915274
- FEI Number
- 2915274
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 4000 Alfred Nobel Drive
- City
- Hercules
- State
- CA
- ZIP
- 94547
- Country
- US
Regulatory Submissions
- 510(k) Number
- K060466
- PMA Number
- BP140111
Owner / Operator
- Firm Name
- Bio-Rad Laboratories, Inc.
- Operator Number
- 9929003
- Address
- 4000 Alfred Nobel Drive, --
- City
- Hercules
- State
- CA
- Postal Code
- 94547
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2012-12-20 |
| Antibodies, Gliadin | MST | Class 2 | Immunology | No | 2014-06-02 |
| Hemoglobin A2 Quantitation | JPD | Class 2 | Hematology | No | 2008-04-17 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2008-04-17 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2010-01-04 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2010-01-04 |
| Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | MOB | Class 2 | Immunology | No | 2010-01-04 |
| Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) | MVJ | Class 2 | Immunology | No | 2010-01-04 |
| Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease | NVI | Class 2 | Clinical Toxicology | No | 2010-01-04 |
| Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | MYF | Class 2 | Microbiology | No | 2010-01-04 |
| Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | MXJ | Class 2 | Microbiology | No | 2010-01-04 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2014-11-03 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2014-11-03 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2014-11-03 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2014-11-03 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2014-11-03 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2014-11-03 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2014-11-03 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2014-11-03 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2014-11-03 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2014-11-03 |
| Instrumentation, High Pressure Liquid Chromatography | LDM | Class 1 | Clinical Chemistry | No | 2008-04-17 |
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2016-02-08 |
| Autoantibodies, Endomysial(Tissue Transglutaminase) | MVM | Class 2 | Immunology | No | 2013-10-31 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2013-10-31 |
| Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus | OPL | Class 2 | Microbiology | No | 2010-12-01 |
| Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | LJB | Class 1 | Microbiology | No | 2010-12-01 |
| Enzyme Linked Immunoabsorbent Assay, Mumps Virus | LJY | Class 1 | Microbiology | No | 2010-12-01 |
| Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | LFY | Class 2 | Microbiology | No | 2010-12-01 |
| Hemoglobin A1c Test System | PDJ | Class 2 | Clinical Chemistry | No | 2016-12-09 |
| Station, Pipetting And Diluting, For Clinical Use | JQW | Class 1 | Clinical Chemistry | No | 2011-11-23 |
| System, Test, Vitamin D | MRG | Class 2 | Clinical Chemistry | No | 2018-06-28 |
| Reagent, Borrelia Serological Reagent | LSR | Class 2 | Microbiology | No | 2019-03-28 |
| Pneumocystis Carinii | LYF | Class 2 | Microbiology | No | 2024-12-06 |
| Abnormal Hemoglobin Quantitation | GKA | Class 2 | Hematology | No | 2008-05-05 |
| Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | LJM | Class 2 | Immunology | No | 2008-04-17 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2015-06-10 |
| Anti-Sm Antibody, Antigen And Control | LKP | Class 2 | Immunology | No | 2006-04-25 |
| Antinuclear Antibody, Antigen, Control | LKJ | Class 2 | Immunology | No | 2006-04-25 |
| Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | LRM | Class 2 | Immunology | No | 2006-04-25 |
| Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | DHN | Class 2 | Immunology | No | 2024-12-06 |
| Reagents For Molecular Diagnostic Test Systems | PFT | Class 1 | Clinical Chemistry | No | 2016-06-23 |
| Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | DBM | Class 2 | Immunology | No | 2024-12-06 |
| Epstein-Barr Virus, Other | LSE | Class 1 | Microbiology | No | 2007-02-12 |
| Antibody Igm,If, Cytomegalovirus Virus | LKQ | Class 2 | Microbiology | No | 2017-05-25 |
| Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm | PUQ | Class 2 | Microbiology | No | 2017-05-25 |
| Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | LFZ | Class 2 | Microbiology | No | 2017-05-25 |
| Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | LGD | Class 2 | Microbiology | No | 2017-05-25 |
| Extractable Antinuclear Antibody, Antigen And Control | LLL | Class 2 | Immunology | No | 2008-04-17 |
| Calibrator For Hemoglobin And Hematocrit Measurement | KRZ | Class 2 | Hematology | No | 2007-05-16 |
| System, Test, Infectious Mononucleosis | KTN | Class 2 | Immunology | No | 2007-03-07 |
| System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | MSV | Class 2 | Immunology | No | 2012-07-17 |
| System, Test, Anticardiolipin Immunological | MID | Class 2 | Immunology | No | 2012-07-17 |
| Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | CDF | Class 1 | Clinical Chemistry | No | 2008-04-17 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2012-12-20 |
| Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | NHX | Class 2 | Immunology | No | 2011-12-29 |
| System, Test, Thyroid Autoantibody | JZO | Class 2 | Immunology | No | 2012-12-20 |
| Droplet Digital Pcr System | PHG | Class 2 | Clinical Chemistry | No | 2026-06-01 |
| Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv | OMI | Class 2 | Microbiology | No | 2010-01-04 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2013-04-30 |
| Bcr/Abl1 Monitoring Test | OYX | Class 2 | Medical Genetics | No | 2019-05-28 |
| Test, Hiv Detection | MZF | Class 2 | Microbiology | No | 2015-08-14 |
| Chromatographic/Fluorometric Method, Catecholamines | CHQ | Class 1 | Clinical Chemistry | No | 2008-04-16 |
| Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | LHL | Class 2 | Microbiology | No | 2024-12-06 |
| Antibody Igm, If, Epstein-Barr Virus | LJN | Class 1 | Microbiology | No | 2013-02-05 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2012-12-20 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2015-08-14 |
| Anti-Dna Indirect Immunofluorescent Solid Phase | KTL | Class 2 | Immunology | No | 2012-12-20 |
| Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | LIP | Class 2 | Microbiology | No | 2017-05-25 |
| Antigens, Nontreponemal, All | GMQ | Class 2 | Microbiology | No | 2017-05-25 |
| Anti-Rnp Antibody, Antigen And Control | LKO | Class 2 | Immunology | No | 2006-04-25 |
| Anti-Ribosomal P Antibodies | MQA | Class 2 | Immunology | No | 2006-06-27 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 1977-12-31 |
Proprietary Names
TOX/See Drug Screen Test-BUP
Bio-Rad DGP-A and DGP-G
VARIANT II with CDM 4
BioPlex Vasculitis Kit
ANA Screen with MDSS
VARIANT II Turbo Hemoglobin Testing System
BioPlex HSV-1 & HSV-2 Kit
TOX/See Drug Screen Test
VARIANT II TURBO with CDM 4
Kallestad Anti-Neutrophil Cytoplasmic Antibodies (ANCA) Test System
BioPLex 2200 System
TOX/See Drug Screen Test-PCP
BioPlex 2200 Celiac IgA and IgG
BioPlex 2200 MMRV IgG
TOX/See Drug Screen Test-COC
D-10 Hemoglobin A1c Program
D-10 Hemoglobin Testing System
PhD lx System
PhD lx Workstation
PhD System
BioPlex 2200 25-OH Vitamin D
BioPlex 2200 Lyme Total
D-100 Hemoglobin Testing System
Monofluo Pneumocystis IFA, MONOFLUO Pneumocystis jirovecii IFA
VARIANTnbs with GDM 3
Autoimmune EIA Anti-Scl-70
VARIANT II TURBO Link Hemoglobin Testing System
VARIANT II TURBO Hemoglobin Testing System
VARIANTnbs Newborn Screening System
VARIANTnbs Sickle Cell Program
ENZYME IMMUNOASSAY ANT
ENZYME IMMUNOASSAY ANTINUCLEA
Autoimmune EIA ANA Screening Test Kit (96 Test)
DiaSorin EIA ANA Screen Test Kit
Autoimmune EIA ANA Screening Test Kit (576 Test)
Meridian EIA ANA Screen Test Kit
Quest EIA ANA Screen Test Kit
Trinity EIA ANA Screen Test Kit
Autoimmune EIA Anti-dsDNA
Kallestad Mouse Stomach Kidney Slide
QXDx Universal Kit for ddPCR System
QXDx Supermix Pack
QXDx Droplet Reader Oil Pack
QXDx Consumable Pack
Kallestad HEp-2 Slide
BioPlex 2200 EBV IgG Kit
Autoimmune EIA Anti-Jo-1
Autoimmune EIA ANA-6 Profile
BioPlex 2200 ToRC IgM
Autoimmune EIA Anti-Centromere
VARIANT II TURBO LINK
VARIANT II Hemoglobin Testing Sys.
VARIANT II HbA1c Program (New)
BIOPLEX 2200 EBV IGM PANEL ON
TOX/See Drug Screen Test-MTD
BioPlex 2200 HSV-1 & HSV-2 IgG
BioPlex 2200 APLS IgG and IgA kit
BioPlex 2200 APLS IgM
VMA by HPLC
TOX/See Drug Screen Test-AMP
TOX/See Drug Screen Test-MDMA
BioPlex 2200 ANA Screen with MDSS
TOX/See Drug Screen Test-BZO
BioPlex 2200 Anti-CCP Kit
Kallestad Anti-Thyroglobulin (Tg) Microplate EIA
QXDx Automated Droplet Generator IVD
QX600Dx Droplet Reader
QXDx AutoDG Supermix Pack B
QXDX Droplet Reader
Kallestad Crithidia (nDNA)
BioPlex ToRC IgG Kit
TOX/See Drug Screen Test-TCA
TOX/See Drug Screen Test-MET
Autoimmune EIA Anti-SS-A/Ro
VARIANT II TURBO Hb Testing System
VARIANT II TURBO HbA1c Program
Autoimmune EIA ENA Plus
Hemoglobin Variants System on the Newborn Hemoglobin System with GDM and HbReview software
Accessory Component for the PhD lx IFA/ EIA Processing and PhD Testing Sytems
PR4100
QXDx Droplet Reader
QXDx BCR-ABL %IS Kit
QXDx Automated Droplet Generator
Autoimmune EIA Anti-SS-B/La
BioPlex 2200 HIV Ag-Ab
Plasma Catecholamines by HPLC
Kallestad Anti-CCP II Microplate EIA
VARIANT II TURBO Link HbA1c Program
VARIANT II TURBO HbA1c Kit - 2
VARIANT Dual Kit
VARIANT II Dual Kit
Monofluo Legionella IFA
BioPlex 2200 EBV IgM
TOX/See Drug Screen Test-BAR
Hemoglobin Capillary Collection System (HCCS) 100 test
Hemoglobin Capillary Collection System (HCCS) 5000 test
Hemoglobin Capillary Collection System (HCCS) 5 test
TOX/See Drug Screen Test-OPI
BioPlex 2200 25-OH Vitamin D Kit
TOX/See Drug Screen Test-THC
D-10 Dual Program
Kallestad Anti-dsDNA Microplate EIA
VARIANT II TURBO Link HbA1c
BioPlex 2200 Syphilis Total & RPR
VARIANT II TURBO HbA1c Kit 2
D-10 Hemoglobin A1c Program Reorder Pack
ENZYME IMMUNOASSAY ANTI
Clinical Data Management (CDM)
VARIANT II HbA1c T Kit
VARIANT II TURBO HbA1c Kit - 2 (Export)
BIOPLEX 2200 ANA SCREEN
BIOPLEX 2200 MULTI-AN
TOX/See Drug Screen Test-PPX
BioPlex 2200 ToRC IgM kit
BioPlex 2200 Instrument
VARIANT II Beta-Thalassemia Short
VARIANT II Hemoglobin A1c Program
VARIANT II Hemoglobin Testing System with CDM Software
TOX/See Drug Screen Test-OXY
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Device in the United States for Export Only
Repack or Relabel Medical Device