Product code MRS
- Device name
- Test System, Nicotine, Cotinine, Metabolites
- Medical specialty
- Clinical Toxicology
- Device class
- 1
- Regulation number
- 862.3220
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06936983197090 | iScreenTM Oral Fluid Drug Test | Hangzhou AllTest Biotech Co., Ltd. | 2025-09-26 |
| 06974246462349 | FIRSTVIEW COT Urine Dip Card Test | Safecare Biotech (Hangzhou) Co., Ltd. | 2025-07-07 |
| 16970429843414 | co-innovation | Co-Innovation Biotech Co., Ltd | 2025-05-19 |
| 06970429843417 | co-innovation | Co-Innovation Biotech Co., Ltd | 2025-05-19 |
| 06936983177252 | FirstCheck Cotinine Oral Fluid Test | Hangzhou AllTest Biotech Co., Ltd. | 2025-02-14 |
| 10816862026198 | Prime Screen | WONDFO USA CO., LTD. | 2024-12-24 |
| 00816862026191 | Prime Screen | WONDFO USA CO., LTD. | 2024-12-24 |
| 06977469280158 | U-Catch Cotinine (COT) Test Dip Card(Colloidal Gold) | Eterbio, Inc. | 2024-12-18 |
| 06977469280097 | U-Catch Cotinine (COT) Test Dip Card(Colloidal Gold) | Eterbio, Inc. | 2024-12-18 |
| 00850065976303 | UScreen Oral | Guangzhou Decheng Biotechnology Co., LTD | 2024-09-27 |
| 00850065976297 | UScreen Oral | Guangzhou Decheng Biotechnology Co., LTD | 2024-09-27 |
| 00850065976280 | UScreen Oral | Guangzhou Decheng Biotechnology Co., LTD | 2024-09-27 |
| 30850054867026 | Amazewell | Guangzhou Decheng Biotechnology Co., LTD | 2024-09-26 |
| 00850054867025 | Amazewell | Guangzhou Decheng Biotechnology Co., LTD | 2024-09-26 |
| 20810038636447 | Easy@Home Nicotine Urine Test (5 tests one kit) | EASY HEALTHCARE CORPORATION | 2024-07-17 |
| 00810038636443 | Easy@Home Nicotine Urine Test (5 tests one kit) | EASY HEALTHCARE CORPORATION | 2024-07-17 |
| 06974246461465 | T Testahead Cotinine(COT) Urine Test Dipcard | Safecare Biotech (Hangzhou) Co., Ltd. | 2024-06-27 |
| 06974246461472 | T Testahead Cotinine(COT) Urine Test Dipcard | Safecare Biotech (Hangzhou) Co., Ltd. | 2024-06-27 |
| 06974246461489 | T Testahead Cotinine(COT) Urine Test Dipcard | Safecare Biotech (Hangzhou) Co., Ltd. | 2024-06-27 |
| 06974246461007 | EXPLORO Highly Sensitive NICOTINE URINE TEST | Safecare Biotech (Hangzhou) Co., Ltd. | 2023-12-01 |
| 06974246460987 | EXPLORO Highly Sensitive NICOTINE URINE TEST | Safecare Biotech (Hangzhou) Co., Ltd. | 2023-12-01 |
| 06974246460994 | EXPLORO Highly Sensitive NICOTINE URINE TEST | Safecare Biotech (Hangzhou) Co., Ltd. | 2023-12-01 |
| 00810038634661 | Areta Cotinine Test Strip(25tests one kit) | EASY HEALTHCARE CORPORATION | 2023-07-19 |
| 00810038634654 | Areta Cotinine Test Strip -COT(10 tests one kit) | EASY HEALTHCARE CORPORATION | 2023-07-19 |
| 00817405022526 | iScreen™ | Instant Technologies, Inc. | 2023-02-07 |
| 00817405021666 | iCassette™ | Instant Technologies, Inc. | 2023-02-07 |
| 06972428161349 | U-Catch | Shenzhen Bioeasy Biotechnology Co., Ltd | 2022-12-08 |
| 00859410006108 | Salimetrics | SALIMETRICS, LLC | 2018-09-14 |
| 10763924047182 | Accutest NicAlert Urine Cotinine Test | JANT PHARMACAL CORPORATION | 2016-09-24 |
| 10763924043580 | Accutest NicAlert Saliva Cotinine Test | JANT PHARMACAL CORPORATION | 2016-09-24 |