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Bio-Rad Laboratories, Inc.

United StatesFDA applicant, unverified FDA FEI 3002701146

Devices
85
Registrations
FDA
FDA recalls
0

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.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Company details

FDA FEI number
3002701146
DUNS number
844766394
Address
14620 NE North Woodinville Way, Woodinville, WA, 98072
Phone
+1(800)224-6723

From the company website

Read 18 Oct 2026

Bio-Rad is a global leader in developing and manufacturing a wide range of products for the life science research and clinical diagnostic markets.

From the manufacturer's own website. Source