Product code NGL
- Device name
- Test, Opiates, Over The Counter
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3650
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | Healgen Scientific,, LLC | 2025-12-23 |
| K250803 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | Anhui Deepblue Medical Technological Co., Ltd. | 2025-04-15 |
| K250067 | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro | Guangzhou Decheng Biotechnology Co., Ltd. | 2025-02-20 |
| K242428 | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus | Guangzhou Decheng Biotechnology Co., Ltd. | 2025-02-06 |
| K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup | Healgen Scientific,, LLC | 2024-12-17 |
| K243064 | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test | Eterbio, Inc. | 2024-11-20 |
| K242802 | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette | Hangzhou Clongene Biotech Co., Ltd. | 2024-11-08 |
| K241869 | BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-10-04 |
| K241969 | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel | Qingdao Hightop Biotech Co., Ltd. | 2024-08-14 |
| K241741 | SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel | Guangzhou Wondfo Biotech Co., Ltd. | 2024-07-16 |
| K241100 | Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2024-05-22 |
| K240949 | Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accu... | Healgen Scientific,, LLC | 2024-05-13 |
| K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | Healgen Scientific,, LLC | 2024-04-12 |
| K240654 | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette | Safecare Biotech (Hangzhou) Co., Ltd. | 2024-04-10 |
| K240295 | InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) | Instanosis, Inc. | 2024-03-28 |
| K234006 | AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test | Allsource Screening Solutions | 2024-03-21 |
| K240351 | FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) | Assure Tech., LLC | 2024-03-06 |
| K233417 | AllTest Fentanyl Urine Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | 2023-10-26 |
| K193480 | BIOEASY Multi-Drug Test Cup | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2020-01-31 |
| K190412 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup | Hangzhou Clongene Biotech Co., Ltd. | 2019-03-21 |
| K181790 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup | Hangzhou Clongene Biotech Co., Ltd. | 2018-07-26 |
| K100108 | AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA | Amedica Biotech, Inc. | 2010-04-14 |
| K082898 | AMEDICA DRUG SCREEN TEST CUP | Amedica Biotech, Inc. | 2008-12-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06937339211507 | BioSieve | Vivachek Biotech (Hangzhou) Co., Ltd. | 2026-10-14 |
| 06937339211538 | BioSieve | Vivachek Biotech (Hangzhou) Co., Ltd. | 2026-10-14 |
| 00311917077932 | Walgreens | WALGREEN CO. | 2026-10-14 |
| 06974541566049 | BioTeke | Bioteke Corporation (Wuxi) Co., Ltd. | 2026-10-13 |
| 06942598249383 | One Step® Buprenorphine (BUP10) Home Rapid Test Dipstick | Hangzhou AllTest Biotech Co., Ltd. | 2026-10-12 |
| 06942598249420 | One Step® Morphine (MOP/OPI2000) Home Rapid Test Dipstick | Hangzhou AllTest Biotech Co., Ltd. | 2026-10-12 |
| 06936983114301 | Alltest MOP2000 Rapid Test Dipstick (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983114226 | Alltest OXY100 Rapid Test Dipstick (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983114325 | Alltest MOP300 Rapid Test Dipstick (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983114400 | Alltest MOP2000 Rapid Test Panel (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983114417 | Alltest OXY100 Rapid Test Panel (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983114462 | Alltest BUP10 Rapid Test Panel (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983114486 | Alltest OXY100 Home Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983114561 | Alltest BUP10 Home Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983114615 | Alltest MOP300 Home Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983114639 | Alltest OXY100 Home Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983114714 | Alltest BUP10 Home Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983114240 | Alltest MOP300 Rapid Test Dipstick (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983114202 | Alltest BUP10 Rapid Test Dipstick (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983114134 | Alltest OXY100 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983114127 | Alltest MOP2000 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983114103 | Alltest MOP300 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983114042 | Alltest BUP10 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983113984 | Alltest OXY100 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983113977 | Alltest MOP2000 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983113953 | Alltest MOP300 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983113892 | Alltest BUP10 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-17 |
| 06936983114790 | Alltest Multi-Drug 15 Drugs Rapid Test Panel (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-16 |
| 06936983114806 | Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-16 |
| 06936983114813 | Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-16 |