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Hangzhou Clongene Biotech Co., Ltd.: FDA-registered device maker in Hangzhou Zhejiang, China, 8 510(k) clearances

Name: Hangzhou Clongene Biotech Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hangzhou Clongene Biotech Co., Ltd. is registered with the FDA (registration 3009414546) in Hangzhou Zhejiang, China. It lists 21 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 30, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009414546
Address: No.1 Yichuang Road, Yuhang Sub-district Yuhang District, Hangzhou Zhejiang, China, 311121
Owner or operator: Hangzhou Clongene Biotech Co., Ltd. (10051623)
Roles: Manufacturer
First device listed: April 12, 2016
Registered through: 2026
Brand names listed: CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Drug Tests Cassette, CLUNGENE Drug Tests Cup, CLUNGENE Drug Tests Dip Card, CLUNGENE Fentanyl Home Test Cassette, CLUNGENE Fentanyl Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Cassette and more

Devices it lists

Device	Product code	Class	Role	Source
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	GQG	1	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Amphetamine	DKZ	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Manufacturer	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Manufacturer	accessdata.fda.gov
Test, Amphetamine, Over The Counter	NFT	2	Manufacturer	accessdata.fda.gov
Test, Barbiturate, Over The Counter	PTH	2	Manufacturer	accessdata.fda.gov
Test, Benzodiazepine, Over The Counter	NFV	2	Manufacturer	accessdata.fda.gov
Test, Cannabinoid, Over The Counter	NFW	2	Manufacturer	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The Counter	NFY	2	Manufacturer	accessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The Counter	NGA	1	Manufacturer	accessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The Counter	NGE	1	Manufacturer	accessdata.fda.gov
Test, Methadone, Over The Counter	PTG	2	Manufacturer	accessdata.fda.gov
Test, Methamphetamine, Over The Counter	NGG	2	Manufacturer	accessdata.fda.gov
Test, Opiates, Over The Counter	NGL	2	Manufacturer	accessdata.fda.gov
Test, Phencyclidine (Pcp), Over The Counter	NGM	U	Manufacturer	accessdata.fda.gov
Test, Propoxyphene, Over The Counter	QBF	2	Manufacturer	accessdata.fda.gov
Test, Tricyclic Antidepressants, Over The Counter	QAW	2	Manufacturer	accessdata.fda.gov
Thin Layer Chromatography, Methamphetamine	DJC	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 30, 2026	K253318	Clungene RSV Antigen Rapid Test	GQG	Substantially Equivalent	Hangzhou Clongene Biotech Co., Ltd.	accessdata.fda.gov
August 27, 2025	K252118	CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup	NFT	Substantially Equivalent	Hangzhou Clongene Biotech Co., Ltd.	accessdata.fda.gov
November 8, 2024	K242802	CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette	NGL	Substantially Equivalent	Hangzhou Clongene Biotech Co., Ltd.	accessdata.fda.gov
December 11, 2019	K193132	CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream	LCX	Substantially Equivalent	Hangzhou Clongene Biotech Co., Ltd.	accessdata.fda.gov
July 26, 2018	K181790	CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup	NGL	Substantially Equivalent	Hangzhou Clongene Biotech Co., Ltd.	accessdata.fda.gov
February 28, 2018	K180255	CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup	PTH	Substantially Equivalent	Hangzhou Clongene Biotech Co., Ltd.	accessdata.fda.gov
August 30, 2016	K161251	CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests	DKZ	Substantially Equivalent	Hangzhou Clongene Biotech Co., Ltd.	accessdata.fda.gov
March 18, 2016	K153741	CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test	LDJ	Substantially Equivalent	Hangzhou Clongene Biotech Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated January 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.