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Cotinine ELISA

DRG International Inc · Model EIA-5917 · UDI-DI 00840239059178

MRS Prescription
3
510(k) clearances
2
Adverse events
1
Recalls
33
Facilities

Description

The Cotinine ELISA Kit is intended for the measurement of Cotinine in serum, urine.

Recalls

DateFirmReason
2020-01-21Polymer Technology Systems, Inc.The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.