Test, Opiates, Over The Counter

FDA product code NGL · 23 cleared devices

Class 2 Clinical Toxicology

Regulation: 21 CFR 862.3650
Review panel: TX
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 2008-12-19 – 2025-12-23

NGL 2025-12-23

Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card

Applicant Healgen Scientific,, LLC

K number K253567

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NGL 2025-04-15

Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup

Applicant Anhui Deepblue Medical Technological Co., Ltd.

K number K250803

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NGL 2025-02-20

Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro

Applicant Guangzhou Decheng Biotechnology Co., Ltd.

K number K250067

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NGL 2025-02-06

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

Applicant Guangzhou Decheng Biotechnology Co., Ltd.

K number K242428

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NGL 2024-12-17

Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup

Applicant Healgen Scientific,, LLC

K number K243365

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NGL 2024-11-20

ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test

Applicant Eterbio, Inc.

K number K243064

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NGL 2024-11-08

CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette

Applicant Hangzhou Clongene Biotech Co., Ltd.

K number K242802

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NGL 2024-10-04

BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader

Applicant Vivachek Biotech (Hangzhou) Co., Ltd.

K number K241869

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NGL 2024-08-14

Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel

Applicant Qingdao Hightop Biotech Co., Ltd.

K number K241969

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NGL 2024-07-16

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

Applicant Guangzhou Wondfo Biotech Co., Ltd.

K number K241741

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NGL 2024-05-22

Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard

Applicant Co-Innovation Biotech Co., Ltd.

K number K241100

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NGL 2024-05-13

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® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)

Applicant Healgen Scientific,, LLC

K number K240949

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NGL 2024-04-12

Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card

Applicant Healgen Scientific,, LLC

K number K240686

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NGL 2024-04-10

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette

Applicant Safecare Biotech (Hangzhou) Co., Ltd.

K number K240654

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NGL 2024-03-28

InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)

Applicant Instanosis, Inc.

K number K240295

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NGL 2024-03-21

AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test

Applicant Allsource Screening Solutions

K number K234006

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NGL 2024-03-06

FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)

Applicant Assure Tech., LLC

K number K240351

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NGL 2023-10-26

AllTest Fentanyl Urine Test Cassette

Applicant Hangzhou AllTest Biotech Co., Ltd.

K number K233417

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NGL 2020-01-31

BIOEASY Multi-Drug Test Cup

Applicant Shenzhen Bioeasy Biotechnology Co., Ltd.

K number K193480

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NGL 2019-03-21

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup

Applicant Hangzhou Clongene Biotech Co., Ltd.

K number K190412

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NGL 2018-07-26

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup

Applicant Hangzhou Clongene Biotech Co., Ltd.

K number K181790

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NGL 2010-04-14

AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA

Applicant Amedica Biotech, Inc.

K number K100108

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NGL 2008-12-19

AMEDICA DRUG SCREEN TEST CUP

Applicant Amedica Biotech, Inc.

K number K082898

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