Data / Medical devices / China / Guangzhou Wondfo Biotech Co., Ltd.

Guangzhou Wondfo Biotech Co., Ltd.: FDA-registered device maker in Dongguan Guangdong, China, 18 510(k) clearances

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

Guangzhou Wondfo Biotech Co., Ltd. is registered with the FDA (registration 3023322455) in Dongguan Guangdong, China. It lists 44 device types. The FDA files 18 510(k) clearances under its listings, the newest dated April 28, 2026. Registered through 2027. FDA data exported November 3, 2026.

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Get makers like this one Watch Guangzhou Wondfo Biotech Co., Ltd.

FDA registration number: 3023322455
Address: Building 1, No.2 Huangqi Street, Songshan Lake Park, Dongguan Guangdong, China, 523787
Owner or operator: GUANGZHOU WONDFO BIOTECH CO., LTD. (9064561)
Roles: Contract manufacturer, Manufacturer
First device listed: January 1, 2008
Registered through: 2027
Brand names listed: 2SAN Home Drug Test Kit, 2San COVID-19 Rapid Self-Test, 2San Colorectal Health Test (immunochemical fecal occult blood test), Areta Multi-Drug Test Cup, Areta Multi-Drug Test Cup, ACDOA-1144, Areta Multi-Drug Test Cup, ACDOA-264, Areta Multi-Drug Test Cup, ACDOA-6125B, Areta Multi-Drug Test Cup, ACDOA-754 and more

Devices it lists

Device	Product code	Class	Role	Source
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	DIC	2	Contract manufacturer	accessdata.fda.gov
Antigens, All Groups, Streptococcus Spp.	GTY	1	Manufacturer	accessdata.fda.gov
Container, Specimen Mailer And Storage, Non-Sterile	NNK	1	Manufacturer	accessdata.fda.gov
Container, Specimen, Non-Sterile	NNI	1	Manufacturer	accessdata.fda.gov
Covid-19 Multi-Analyte Antigen Device	QMN	N	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Amphetamine	DKZ	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	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
Enzyme Immunoassay, Phencyclidine	LCM	U	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Propoxyphene	JXN	2	Manufacturer	accessdata.fda.gov
Gas Chromatography, Methamphetamine	LAF	2	Manufacturer	accessdata.fda.gov
Immunoassay, Pregnanediol Glucuronide, Over The Counter	QKE	1	Manufacturer	accessdata.fda.gov
Kit, Direct Antigen, Positive Control	MJZ	1	Manufacturer	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Manufacturer	accessdata.fda.gov
Multi-Analyte Respiratory Virus Antigen Detection Test	SCA	2	Manufacturer	accessdata.fda.gov
Over-The-Counter Covid-19 Antigen Test	QYT	2	Manufacturer	accessdata.fda.gov
Reagent, Occult Blood	KHE	2	Manufacturer	accessdata.fda.gov
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings	QVF	2	Manufacturer	accessdata.fda.gov
System, Test, Human Chorionic Gonadotropin	DHA	2	Manufacturer	accessdata.fda.gov
Test System, Nicotine, Cotinine, Metabolites	MRS	1	Manufacturer	accessdata.fda.gov
Test, Amphetamine, Employment And Insurance Testing, Exempt	PUX	2	Manufacturer	accessdata.fda.gov
Test, Amphetamine, Over The Counter	NFT	2	Manufacturer	accessdata.fda.gov
Test, Barbiturate, Employment And Insurance Testing, Exempt	PUY	2	Manufacturer	accessdata.fda.gov
Test, Barbiturate, Over The Counter	PTH	2	Manufacturer	accessdata.fda.gov
Test, Benzodiazepine, Employment And Insurance Testing, Exempt	PUZ	2	Manufacturer	accessdata.fda.gov
Test, Benzodiazepine, Over The Counter	NFV	2	Manufacturer	accessdata.fda.gov
Test, Cannabinoid, Employment And Insurance Testing, Exempt	PVJ	2	Manufacturer	accessdata.fda.gov
Test, Cannabinoid, Over The Counter	NFW	2	Manufacturer	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	PVA	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, Employment And Insurance Testing, Exempt	PVE	2	Manufacturer	accessdata.fda.gov
Test, Methadone, Over The Counter	PTG	2	Manufacturer	accessdata.fda.gov
Test, Methamphetamine, Employment And Insurance Testing, Exempt	PVD	2	Manufacturer	accessdata.fda.gov
Test, Methamphetamine, Over The Counter	NGG	2	Manufacturer	accessdata.fda.gov
Test, Opiates, Employment And Insurance Testing, Exempt	PVH	2	Manufacturer	accessdata.fda.gov
Test, Opiates, Over The Counter	NGL	2	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
Visual, Pregnancy Hcg, Prescription Use	JHI	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
April 28, 2026	K260065	SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx	NFT	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
November 18, 2025	K252550	SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx	NFT	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
October 22, 2025	K251289	WELLlife COVID-19 Antigen Test Rx	QVF	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
August 20, 2025	K251563	WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test	SCA	Substantially Equivalent	Wondfo USA Co, Ltd.	accessdata.fda.gov
January 16, 2025	K243256	WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest	SCA	Substantially Equivalent	Wondfo USA Co, Ltd.	accessdata.fda.gov
September 30, 2024	K241317	Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)	QYT	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
July 16, 2024	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	NGL	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
September 25, 2020	K202567	Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx	NFT	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
December 3, 2018	K182701	Wondfo T-Cup Multi-Drug Urine Test Cup	NFT	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
May 14, 2017	K162333	Wondfo One Step Fecal Occult Blood (FOB) Test	KHE	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
August 7, 2015	K150022	Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream	LCX	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
February 25, 2014	K133968	WONDFO MULTI-DRUG URINE TEST CUP, PANEL	DKZ	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
January 31, 2014	K133343	WONDFO RAPID STREP A TEST	GTY	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
April 9, 2013	K130665	WONDOFO MULTI-DRUG URINE TEST CUP / PANEL	DJG	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
July 25, 2012	K121557	WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST	LDJ	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
May 20, 2011	K110182	CANNABINOIDS URINE TEST	LDJ	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
April 21, 2009	K072500	ONE STEP HCG URINE/SERUM TEST	DHA	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
April 8, 2005	K043443	ONE STEP HCG URINE PREGNANCY TEST	LCX	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 28, 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.