FDA Registration
Active
🇺🇸 United States
BIO-RAD LABORATORIES, INC.
Reg #: 3032705
·
FEI: 3002701146
·
Expires 2026
Products
39
Proprietary Names
112
Establishment Types
4
Classifications
39
Registration Details
- Registration Name
- BIO-RAD LABORATORIES, INC.
- Registration Number
- 3032705
- FEI Number
- 3002701146
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 14620 NE North Woodinville Way
- City
- Woodinville
- State
- WA
- ZIP
- 98072
- Country
- US
Regulatory Submissions
- 510(k) Number
- K972295
- PMA Number
- P060031
Owner / Operator
- Firm Name
- BIO-RAD LABORATORIES, INC.
- Operator Number
- 3022521
- Address
- 8415 216th St SE, --
- City
- Woodinville
- State
- WA
- Postal Code
- 98072
- Country
- US
- Correspondent
- David - Bhend
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | LFY | Class 2 | Microbiology | No | 2016-04-14 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2014-02-25 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2014-02-25 |
| Autoantibodies, Endomysial(Tissue Transglutaminase) | MVM | Class 2 | Immunology | No | 2014-02-25 |
| Antibodies, Gliadin | MST | Class 2 | Immunology | No | 2014-02-25 |
| Antibody Igm, If, Epstein-Barr Virus | LJN | Class 1 | Microbiology | No | 2016-04-14 |
| Enzyme Linked Immunoabsorbent Assay, Rubella | LFX | Class 2 | Microbiology | No | 2016-04-14 |
| Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus | OPL | Class 2 | Microbiology | No | 2014-06-23 |
| Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | LJB | Class 1 | Microbiology | No | 2014-06-23 |
| Enzyme Linked Immunoabsorbent Assay, Mumps Virus | LJY | Class 1 | Microbiology | No | 2014-06-23 |
| Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | NHX | Class 2 | Immunology | No | 2013-01-31 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2014-06-23 |
| Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv | OMI | Class 2 | Microbiology | No | 2014-06-23 |
| Antinuclear Antibody, Antigen, Control | LKJ | Class 2 | Immunology | No | 2014-06-23 |
| Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | MXJ | Class 2 | Microbiology | No | 2014-06-23 |
| Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | MYF | Class 2 | Microbiology | No | 2014-06-23 |
| Test, Hiv Detection | MZF | Class 2 | Microbiology | No | 2015-08-17 |
| Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | Class 2 | Microbiology | No | 2010-11-02 |
| Qualitative And Quantitative Hepatitis B Virus Antibody Assays | SEI | Class 2 | Microbiology | No | 2010-11-02 |
| Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | LHL | Class 2 | Microbiology | No | 2018-11-13 |
| Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | DHN | Class 2 | Immunology | No | 2008-07-08 |
| Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | DBM | Class 2 | Immunology | No | 2008-07-08 |
| Pneumocystis Carinii | LYF | Class 2 | Microbiology | No | 2008-07-08 |
| System, Test, Vitamin D | MRG | Class 2 | Clinical Chemistry | No | 2015-01-14 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2015-01-14 |
| Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | LGC | Class 2 | Microbiology | No | 2016-04-14 |
| Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm | PUQ | Class 2 | Microbiology | No | 2017-05-24 |
| Antibody Igm,If, Cytomegalovirus Virus | LKQ | Class 2 | Microbiology | No | 2017-05-24 |
| Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | LFZ | Class 2 | Microbiology | No | 2017-05-24 |
| Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | LGD | Class 2 | Microbiology | No | 2017-05-24 |
| Epstein-Barr Virus, Other | LSE | Class 1 | Microbiology | No | 2015-08-25 |
| Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | LIP | Class 2 | Microbiology | No | 2017-05-24 |
| Antigens, Nontreponemal, All | GMQ | Class 2 | Microbiology | No | 2017-05-24 |
| System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | MSV | Class 2 | Immunology | No | 2013-02-27 |
| System, Test, Anticardiolipin Immunological | MID | Class 2 | Immunology | No | 2013-02-27 |
| Reagent, Borrelia Serological Reagent | LSR | Class 2 | Microbiology | No | 2019-03-26 |
| Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) | MVJ | Class 2 | Immunology | No | 2008-01-08 |
| Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | MOB | Class 2 | Immunology | No | 2008-01-08 |
| System, Test, Infectious Mononucleosis | KTN | Class 2 | Immunology | No | 2014-06-23 |
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 Kit
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
BioPlex 2200 Lyme Total Calibrator Set
BioPlex 2200 Lyme Total Control Set
BioPlex 2200 Lyme Total Reagent Pack
SERAQUEST Measles IgG
SERAQUEST EB VCA IGG
BioPlex2200 Vasculitis Reagent Pack
BioPlex2200 Vasculitis Calibrator Set
BioPlex 2200 Vasculitis Control Set
BioPlex 2200 EBV IgM Calibrator Set
BioPlex 2200 EBV IgM Kit
BioPlex 2200 EBV IgM Control Set
BioPlex 2200 EBV IgM
SERAQUEST EB NA IGG
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Device in the United States for Export Only
Manufacture Medical Device