Contract manufacturerBIO-RAD LABORATORIES, INC. (Woodinville, WA)WashingtonImmunologyMicrobiologyClinical chemistryClass IIClass I
BIO-RAD LABORATORIES, INC.
Contract manufacturer · Woodinville, WA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3032705 (openFDA record; or search FDA's registration database)
- FEI number
- 3002701146
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer
- Owner or operator
- BIO-RAD LABORATORIES, INC. (FDA owner/operator no. 3022521)
- Registered address
- 14620 NE North Woodinville Way, Woodinville, WA 98072
- Contract listings
- 18 device listings, 32 product codes, first listed Jan 8, 2008
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | Class II | Immunology | Contract manufacturing | Mar 19, 2013 |
| GMQ | Antigens, Nontreponemal, All | Class II | Microbiology | Contract manufacturing | May 24, 2017 |
| JIT | Calibrator, Secondary | Class II | Clinical chemistry | Contract manufacturing | Jan 14, 2015 |
| JIX | Calibrator, Multi-Analyte Mixture | Class II | Clinical chemistry | Contract manufacturing | Jan 8, 2008 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Class I | Clinical chemistry | Contract manufacturing | Feb 27, 2013 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | Class I | Clinical chemistry | Contract manufacturing | Jan 8, 2008 |
| KTN | System, Test, Infectious Mononucleosis | Class II | Immunology | Contract manufacturing | Jun 23, 2014 |
| LFY | Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | Class II | Microbiology | Contract manufacturing | Jun 23, 2014 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | Class II | Microbiology | Contract manufacturing | May 24, 2017 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | Class II | Microbiology | Contract manufacturing | May 24, 2017 |
| LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | Class II | Microbiology | Contract manufacturing | Jun 23, 2014 |
| LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | Class I | Microbiology | Contract manufacturing | Jun 23, 2014 |
| LJN | Antibody Igm, If, Epstein-Barr Virus | Class I | Microbiology | Contract manufacturing | Jun 23, 2014 |
| LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | Class I | Microbiology | Contract manufacturing | Jun 23, 2014 |
| LKJ | Antinuclear Antibody, Antigen, Control | Class II | Immunology | Contract manufacturing | Jun 23, 2014 |
| LKQ | Antibody Igm,If, Cytomegalovirus Virus | Class II | Microbiology | Contract manufacturing | May 24, 2017 |
| LSE | Epstein-Barr Virus, Other | Class I | Microbiology | Contract manufacturing | Jun 23, 2014 |
| LSR | Reagent, Borrelia Serological Reagent | Class II | Microbiology | Contract manufacturing | Mar 26, 2019 |
| MID | System, Test, Anticardiolipin Immunological | Class II | Immunology | Contract manufacturing | Feb 27, 2013 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | Class II | Immunology | Contract manufacturing | Jan 8, 2008 |
| MRG | System, Test, Vitamin D | Class II | Clinical chemistry | Contract manufacturing | Jan 14, 2015 |
| MST | Antibodies, Gliadin | Class II | Immunology | Contract manufacturing | Feb 25, 2014 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | Class II | Immunology | Contract manufacturing | Feb 27, 2013 |
| MVJ | Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) | Class II | Immunology | Contract manufacturing | Jan 8, 2008 |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | Class II | Immunology | Contract manufacturing | Feb 25, 2014 |
| MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | Class II | Microbiology | Contract manufacturing | Jun 23, 2014 |
| MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | Class II | Microbiology | Contract manufacturing | Jun 23, 2014 |
| MZF | Test, Hiv Detection | Class II | Microbiology | Contract manufacturing | Aug 17, 2015 |
| NHX | Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | Class II | Immunology | Contract manufacturing | Jan 31, 2013 |
| OMI | Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv | Class II | Microbiology | Contract manufacturing | Jun 23, 2014 |
| OPL | Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus | Class II | Microbiology | Contract manufacturing | Jun 23, 2014 |
| PUQ | Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm | Class II | Microbiology | Contract manufacturing | May 24, 2017 |