Home › DRG International Inc › Cotinine direct (serum/urine) ELISA (480 well)
Cotinine direct (serum/urine) ELISA (480 well)
DRG International Inc · Model EIA-5497 · UDI-DI 00840239054975
MRS
Prescription
3
510(k) clearances
2
Adverse events
1
Recalls
33
Facilities
Description
The Cotinine direct (Serum/Urine) ELISA is a specific and sensitive in-vitro test to detect the presence of Cotinine in serum and urine.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-01-21 | Polymer 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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Get your free API keyRead the docsData 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.