Bio-Rad Laboratories, Inc.
United StatesFDA 510(k) applicant, unverified FDA FEI 3002701146
- Devices
- 85
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Bio-Rad Laboratories, Inc. makes
Bio-Rad Laboratories, Inc. manufactures in vitro diagnostic (IVD) reagents and analyzers for clinical laboratories, including enzyme immunoassays (EIA), immunoassay reagents, and automated testing systems. Products include microplate kits for respiratory syncytial virus (RSV) detection, total immunoglobulin E (IgE) assays, troponin I reagents for cardiac markers, and hemoglobin A1c testing programs. The company also supplies reagents for thyroid-stimulating hormone (TSH), cortisol, digoxin, beta-human chorionic gonadotropin (BHCG), and celiac disease screening on multi-analyte detection systems.
The company’s diagnostic devices are classified under FDA categories Class I, Class II, and Class III, with regulatory submissions recorded in 510(k) and PMA pathways. Devices are listed in the FDA’s regulatory database, and the manufacturer is based in the United States.
Catalogue
Search and filter all 85 devicesShowing 1-50 of 85
Company details
- FDA FEI number
- 3002701146
- DUNS number
- 844766394
- Address
- 14620 NE North Woodinville Way, Woodinville, WA, 98072
- Website
- www.bio-rad.com
- linkedin.com/company/bio-rad
- facebook.com/biorad
- [email protected]
- Phone
- +1(800)224-6723
From the company website
Bio-Rad is a global leader in developing and manufacturing a wide range of products for the life science research and clinical diagnostic markets.
Frequently asked questions
How many devices does Bio-Rad Laboratories, Inc. have in the registry?
The registry currently lists 85 devices for Bio-Rad Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bio-Rad Laboratories, Inc.'s devices?
Among its 50 most recently registered devices, Bio-Rad Laboratories, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Bio-Rad Laboratories, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Bio-Rad Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bio-Rad Laboratories, Inc. in the registry?
The most recently registered devices listed for Bio-Rad Laboratories, Inc. include KALLESTAD RSV MICROPLATE EIA, ACCESS(R) TOTAL IGE ASSAY, ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329 and BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200.