Product code NGL— Clinical Toxicology
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
- Classification name
- Test, Opiates, Over The Counter
- Device class
- Class 2
- Regulation
- 21 CFR 862.3650
- Advisory panel
- Clinical Toxicology
- Total cleared
- 23
- First cleared
- Most recent
Market context for product code NGL
FDA has cleared devices under product code NGL between 2008 and 2025, filed by 16 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2025
- 2024
- 2023
- 2020
- 2019
- 2018
- 2010
- 2008
Top applicants under product code NGL
- Healgen Scientific,, LLC
- Hangzhou Clongene Biotech Co., Ltd.
- Guangzhou Decheng Biotechnology Co., Ltd.
- Amedica Biotech, Inc.
- Vivachek Biotech (Hangzhou) Co., Ltd.
- Shenzhen Bioeasy Biotechnology Co., Ltd.
- Safecare Biotech (Hangzhou) Co., Ltd.
- Qingdao Hightop Biotech Co., Ltd.
- Instanosis, Inc.
- Hangzhou AllTest Biotech Co., Ltd.
Recent clearances under product code NGL
- K253567 — Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
- K250803 — Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup
- K250067 — Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro
- 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
- K243365 — Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup
- K243064 — ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test
- K242802 — CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette
- K241869 — BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader
- K241969 — Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel
- K241741 — SAFElife Fentanyl Urine Home Test (Cassette) +3 more
- K241100 — Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard
- K240949 — Healgen® Accurate Fentanyl Rapid Test Cassette (Urine) +5 more
- K240686 — Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
- K240654 — SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette
- K240295 — InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)
- K234006 — AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test
- K240351 — FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)
- K233417 — AllTest Fentanyl Urine Test Cassette
- K193480 — BIOEASY Multi-Drug Test Cup
- K190412 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
- K181790 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
- K100108 — AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA
- K082898 — AMEDICA DRUG SCREEN TEST CUP
Data sourced from openFDA. This site is unofficial and independent of the FDA.