Data / Medical devices / Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO): 63 FDA-registered makers in 7 countries

63 establishments in 7 countries are registered with the FDA to make Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO, Class 2, 21 CFR 862.3250). 23 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 145 510(k) clearances under this code, the latest on January 27, 2022, and lists 11 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

DIO

Device class

2

Regulation

862.3250

Medical specialty

Clinical Toxicology

Makers by country

Makers of Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated January 27, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.