Test, Opiates, Over The Counter
FDA product code NGL · Class II (moderate risk) · 21 CFR 862.3650 · Clinical Toxicology
23510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Healgen Scientific,, LLC 4
- Hangzhou Clongene Biotech Co., Ltd. 3
- Amedica Biotech, Inc. 2
- Guangzhou Decheng Biotechnology Co., Ltd. 2
- Shenzhen Bioeasy Biotechnology Co., Ltd. 1
- Hangzhou AllTest Biotech Co., Ltd. 1
- Assure Tech., LLC 1
- Allsource Screening Solutions 1
- Instanosis, Inc. 1
- Safecare Biotech (Hangzhou) Co., Ltd. 1
- Co-Innovation Biotech Co., Ltd. 1
- Guangzhou Wondfo Biotech Co., Ltd. 1
- Qingdao Hightop Biotech Co., Ltd. 1
- Vivachek Biotech (Hangzhou) Co., Ltd. 1
- Eterbio, Inc. 1
- Anhui Deepblue Medical Technological Co., Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…NGL · Traditional | Healgen Scientific,, LLC | 12/23/2025SE |
| K250803 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test CupNGL · Traditional | Anhui Deepblue Medical Technological Co., Ltd. | 04/15/2025SE |
| K250067 | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup ProNGL · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 02/20/2025SE |
| K242428 | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek®…NGL · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 02/06/2025SE |
| K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine…NGL · Traditional | Healgen Scientific,, LLC | 12/17/2024SE |
| K243064 | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl…NGL · Traditional | Eterbio, Inc. | 11/20/2024SE |
| K242802 | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test CassetteNGL · Traditional | Hangzhou Clongene Biotech Co., Ltd. | 11/08/2024SE |
| K241869 | BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve…NGL · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 10/04/2024SE |
| K241969 | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop®…NGL · Traditional | Qingdao Hightop Biotech Co., Ltd. | 08/14/2024SE |
| K241741 | SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test…NGL · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 07/16/2024SE |
| K241100 | Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test DipcardNGL · Traditional | Co-Innovation Biotech Co., Ltd. | 05/22/2024SE |
| K240949 | Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl…NGL · Traditional | Healgen Scientific,, LLC | 05/13/2024SE |
| K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…NGL · Traditional | Healgen Scientific,, LLC | 04/12/2024SE |
| K240654 | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test CassetteNGL · Traditional | Safecare Biotech (Hangzhou) Co., Ltd. | 04/10/2024SE |
| K240295 | InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)NGL · Traditional | Instanosis, Inc. | 03/28/2024SE |
| K234006 | AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl TestNGL · Traditional | Allsource Screening Solutions | 03/21/2024SE |
| K240351 | FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)NGL · Traditional | Assure Tech., LLC | 03/06/2024SE |
| K233417 | AllTest Fentanyl Urine Test CassetteNGL · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 10/26/2023SE |
| K193480 | BIOEASY Multi-Drug Test CupNGL · Traditional | Shenzhen Bioeasy Biotechnology Co., Ltd. | 01/31/2020SE |
| K190412 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupNGL · Traditional | Hangzhou Clongene Biotech Co., Ltd. | 03/21/2019SE |
| K181790 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupNGL · Traditional | Hangzhou Clongene Biotech Co., Ltd. | 07/26/2018SE |
| K100108 | Amedica Drug Test THC, Coc, Opi, Amp, Met, PCP, Bar, Bzo, Mdma, Oxy, TcaNGL · Special | Amedica Biotech, Inc. | 04/14/2010SE |
| K082898 | Amedica Drug Screen Test CupNGL · Traditional | Amedica Biotech, Inc. | 12/19/2008SE |