Home › Device types › MRS
Test System, Nicotine, Cotinine, Metabolites
FDA product code MRS · Class 1 · Clinical Toxicology
47
Registered devices
2
Adverse events
1
Recalls
3
510(k) clearances
Devices with this code
AlereTM iScreen® OFD — Instant Technologies, Inc.Cotinine direct (serum/urine) ELISA (480 well) — DRG International InciCassette™ — Instant Technologies, Inc.Prime Screen — WONDFO USA CO., LTD.UScreen Oral — Guangzhou Decheng Biotechnology Co., LTDCotinine ELISA — DRG International Increditest® — REDWOOD TOXICOLOGY LABORATORY, INC.U-Catch — Shenzhen Bioeasy Biotechnology Co., LtdEXPLORO Highly Sensitive NICOTINE URINE TEST — Safecare Biotech (Hangzhou) Co., Ltd.FIRSTVIEW COT Urine Dip card Test — Safecare Biotech (Hangzhou) Co., Ltd.UScreen Oral — Guangzhou Decheng Biotechnology Co., LTDSalimetrics — SALIMETRICS, LLCAIMSTEP COTININE — GERMAINE LABORATORIES, INCSalimetrics — SALIMETRICS, LLCU-Catch Cotinine (COT) Test Dip Card(Colloidal Gold) — Eterbio, Inc.NicCheck I — Mossman Associates, Inc.U-Catch Cotinine (COT) Test Dip Card(Colloidal Gold) — Eterbio, Inc.Accutest NicAlert Urine Cotinine Test — JANT PHARMACAL CORPORATIONAmazewell — Guangzhou Decheng Biotechnology Co., LTDAIMSTEP COTININE — GERMAINE LABORATORIES, INCU-Catch — Shenzhen Bioeasy Biotechnology Co., Ltdco-innovation — Co-Innovation Biotech Co., LtdFIRSTVIEW COT Urine Dip Card Test — Safecare Biotech (Hangzhou) Co., Ltd.PTS Detect® Cotinine System — POLYMER TECHNOLOGY SYSTEMS, INC.
Recent 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.