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
T Testahead Cotinine(COT) Urine Test Dipcard — Safecare Biotech (Hangzhou) Co., Ltd.Areta Cotinine Test Strip -COT(10 tests one kit) — EASY HEALTHCARE CORPORATIONCotinine direct (serum/urine) ELISA (96 well) — DRG International IncCotinine (COT) Rapid Test Panel — Hangzhou AllTest Biotech Co., Ltd.U-Catch — Shenzhen Bioeasy Biotechnology Co., Ltdaccutest® — JANT PHARMACAL CORPORATIONAmazewell — Guangzhou Decheng Biotechnology Co., LTDCotinine ELISA — DRG International Increditest® — REDWOOD TOXICOLOGY LABORATORY, INC.Salimetrics — SALIMETRICS, LLCU-Catch — Shenzhen Bioeasy Biotechnology Co., LtdEasy@Home Nicotine Urine Test (5 tests one kit) — EASY HEALTHCARE CORPORATIONFIRSTVIEW COT Urine Dip card Test — Safecare Biotech (Hangzhou) Co., Ltd.Accutest NicAlert Saliva Cotinine Test — JANT PHARMACAL CORPORATIONUScreen Oral — Guangzhou Decheng Biotechnology Co., LTDiScreen™ — Instant Technologies, Inc.Cotinine (COT) Rapid Test Dipstick — Hangzhou AllTest Biotech Co., Ltd.NA — Alere San Diego, Inc.T Testahead Cotinine(COT) Urine Test Dipcard — Safecare Biotech (Hangzhou) Co., Ltd.FIRSTVIEW COT Urine Dip Card Test — Safecare Biotech (Hangzhou) Co., Ltd.iScreenTM Oral Fluid Drug Test — Hangzhou AllTest Biotech Co., Ltd.FirstCheck Cotinine Oral Fluid Test — Hangzhou AllTest Biotech Co., Ltd.EXPLORO Highly Sensitive NICOTINE URINE TEST — Safecare Biotech (Hangzhou) Co., Ltd.EXPLORO Highly Sensitive NICOTINE URINE TEST — Safecare Biotech (Hangzhou) Co., Ltd.
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. |
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