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Rapid Diagnostics Inc

United StatesFDA applicant, unverified

Devices
255

What Rapid Diagnostics Inc makes

Rapid Diagnostics Inc manufactures in vitro diagnostic (IVD) kits and rapid immunochromatographic test (ICT) devices for detecting drugs of abuse, including morphine, benzodiazepines, cocaine, methamphetamine, phencyclidine, and methadone, as well as human chorionic gonadotropin beta-subunit (beta-HCG). Products include multi-panel test kits for simultaneous screening of multiple substances and single-target test strips for specific drugs, designed for clinical and point-of-care use.

The company’s portfolio is regulated under FDA Class II and Class U devices, with submissions recorded in the FDA 510(k) and Unique Device Identifier (UDI) registries. The manufacturer is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Company details

DUNS number
008028248
Phone
+1(800)854-0530

Frequently asked questions

How many devices does RAPID DIAGNOSTICS INC have in the registry?

The registry currently lists 255 devices for RAPID DIAGNOSTICS INC. Devices recorded under merged duplicate company entries are counted once.

Which registries list RAPID DIAGNOSTICS INC's devices?

Among its 50 most recently registered devices, RAPID DIAGNOSTICS INC has devices listed in FDA GUDID (50 devices).

What risk classes do RAPID DIAGNOSTICS INC's devices fall under?

Among its 50 most recently registered devices, the classes recorded for RAPID DIAGNOSTICS INC's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from RAPID DIAGNOSTICS INC in the registry?

The most recently registered devices listed for RAPID DIAGNOSTICS INC include DOA 3 PANEL TEST 07RD7062-15A, DOA 5 PANEL TEST 07RD7064-11, RAPID DIAGNOSTICS M-AMPHAMPHETAMINE TEST STRIP KIT (50) 07RD8005 and DOA 3 PANEL TEST 07RD7062-07.

Generated automatically from registry data and not verified by a human reviewer.