What does Guangzhou Wondfo Biotech Co., Ltd. manufacture?

Registered with the FDA for 44 device types.

Is Guangzhou Wondfo Biotech Co., Ltd. still registered with the FDA?

Yes. The registration is current and expires 2026.

Guangzhou Wondfo Biotech Co., Ltd.

Registered establishment in Guangzhou, Guangdong, China. 44 device types, 43 clearances.

Registry build 21.09.26

Guangzhou Wondfo Biotech Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Reagent, Occult Blood, Enzyme Immunoassay, Opiates and 42 other device types. Its earliest product listing with the FDA dates from 2008.

44device types registered with the FDA

43510(k) clearances

3recalls

Registration

FDA registration record for Guangzhou Wondfo Biotech Co., Ltd.
Registered name	GUANGZHOU WONDFO BIOTECH CO., LTD.
Status	Registered
Registration expires	2026
Registration number	3004635103
FEI number	3004635103
Establishment type	Contract manufacturer, Complaint-file establishment, Manufacturer

Chinese Registration

Chinese company register details for Guangzhou Wondfo Biotech Co., Ltd.
Chinese legal name	广州万孚生物技术股份有限公司
Unified social credit code	91440101618640472W
Source	export sales certificate, Guangdong medical products administration

Location

Address of Guangzhou Wondfo Biotech Co., Ltd.
City	Guangzhou
Province	Guangdong
Address	No.8 Lizhishan Road, Science City, Huangpu District
Postal code	510663
Country	China

What It Makes

Device types Guangzhou Wondfo Biotech Co., Ltd. is registered to make
Device type	Class	Listed under the names	Listed since	Chinese makers
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	Class 2	One Step Saliva Alcohol Test Strip, PRIME SCREEN® Saliva Alcohol Test Strip	2016	2
Antigens, All Groups, Streptococcus Spp.	Class 1	Wondfo Biotech Co. Ltd Preview Strep A Test Kit, Toptolife™ Strep A Test	2014	6
Container, Specimen Mailer And Storage, Non-Sterile	Class 1	TopazFIT Collection Kits	2024	51
Container, Specimen, Non-Sterile	Class 1	Vacu Lid, SAFElife™ T-Cup Drug Adulteration Urine Test Cup	2016	115
Covid-19 Multi-Analyte Antigen Device	Class N	WELLlife™ COVID-19 / Influenza A&B Test Positive Control Swab, WELLlife™ COVID-19 / Influenza A&B Home Test, WELLlife™ COVID-19 / Influenza A&B Test, WELLlife™ COVID-19 / Influenza A&B Test uncut sheet, WELLlife™ COVID-19 / Influenza A&B Home Test uncut sheet, WELLlife™ COVID-19 / Influenza A&B Test Negative Control Swab	2024	7
Enzyme Immunoassay, Amphetamine	Class 2	Easy@Home Multi-Drug Urine Test Cup, Multi-Drug Urine Test Cup, Multi-Drug Urine Test Panel, Easy@Home Multi-Drug Urine Test Panel, Micro Distributing II Ltd. STATCUPII One Step Drug Test Cup, T-Cup Multi-Drug Urine Test Cup, Micro Distributing II Ltd. FASTEST LABS One Step Drug Test Cup and 2 more	2013	16
Enzyme Immunoassay, Barbiturate	Class 2	Easy@Home Multi-Drug Urine Test Cup, Multi-Drug Urine Test Cup, Multi-Drug Urine Test Panel, Easy@Home Multi-Drug Urine Test Panel	2013	12
Enzyme Immunoassay, Benzodiazepine	Class 2	Easy@Home Multi-Drug Urine Test Cup, Multi-Drug Urine Test Cup, Multi-Drug Urine Test Panel, Easy@Home Multi-Drug Urine Test Panel	2013	13
Enzyme Immunoassay, Cannabinoids	Class 2	Easy@Home Multi-Drug Urine Test Cup, Multi-Drug Urine Test Cup, Multi-Drug Urine Test Panel, Easy@Home Multi-Drug Urine Test Panel, SAFElife™ Cannabinoids (THC) Urine Test, PRIME SCREEN® Cannabinoids (THC) Urine Test Strip, PRIME SCREEN® Marijuana (THC) Urine Test Strip and 5 more	2011	18
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Class 2	Easy@Home Multi-Drug Urine Test Cup, Multi-Drug Urine Test Cup, Multi-Drug Urine Test Panel, Easy@Home Multi-Drug Urine Test Panel	2013	16
Enzyme Immunoassay, Opiates	Class 2	Easy@Home Multi-Drug Urine Test Cup, Multi-Drug Urine Test Cup, Multi-Drug Urine Test Panel, Easy@Home Multi-Drug Urine Test Panel	2013	17
Enzyme Immunoassay, Phencyclidine	Class U	Easy@Home Multi-Drug Urine Test Cup, Multi-Drug Urine Test Cup, Multi-Drug Urine Test Panel, Easy@Home Multi-Drug Urine Test Panel, Mintegrity® Multi-Panel Urine Test, Easy@Home® Multi-Drug Screen Test, EDOAP-144, SAFElife™ T-Dip Nortriptyline (TCA) Urine Test Panel and 102 more	2013	16
Enzyme Immunoassay, Propoxyphene	Class 2	RST Home Drug Test Kit Panel (Urine), RST Home Drug Test Kit Cup (Urine), Easy@Home Single Drug Screen Test (Cannabinoids Urine Test), EDTH-114, Easy@Home Single Drug Screen Test (Cannabinoids Urine Test), Marijuana Home Drug Test	2012	10
Gas Chromatography, Methamphetamine	Class 2	Easy@Home Multi-Drug Urine Test Cup, Multi-Drug Urine Test Cup, Multi-Drug Urine Test Panel, Easy@Home Multi-Drug Urine Test Panel	2013	10
Immunoassay, Pregnanediol Glucuronide, Over The Counter	Class 1	Wondfo® PdG Urine Test, HORMONElife™ PdG Urine Test Strip, PdG Test	2023	4
Kit, Direct Antigen, Positive Control	Class 1	WELLlife™ COVID-19 Antigen Test Rx Control Kit, WELLlife COVID-19/Influenza A&B Antigen Test with Control Kit (WELLlife COVID-19/Influenza A&B Antigen Test Control Kit), Clarity COVID-19 Antigen Test Control Kit, WELLlife™ Influenza A&B Test Control Kit, Dealmed COVID-19 / Influenza A&B Antigen Test Control Kit, QuickVue Influenza+SARS Test Control Kit and 3 more	2025	1
Kit, Test, Pregnancy, Hcg, Over The Counter	Class 2	HORMONElife™ Pregnancy Test Strip, HORMONElife™ Fertility Combination Tests (HORMONElife™ Pregnancy Test Strip), HORMONElife™ Pregnancy Home Test Midstream, HORMONElife™ Pregnancy Test Cassette Rx, Easy At Home Medical LLC Easy@Home Early Pregnancy Test (strip), One Step HCG Urine Test and 32 more	2008	30
Multi-Analyte Respiratory Virus Antigen Detection Test	Class 2	MEDLINE Flu A & B Rapid Antigen Cassette Test, Clarity Influenza A&B Test, WELLlife™ Flu A&B Home Test, WELLlife ™ Influenza A&B Test, Clarity COVID-19 / Influenza A&B Antigen Test, WELLlife™ COVID-19 / Flu A&B Home Test uncut sheet and 7 more	2025	4
Over-The-Counter Covid-19 Antigen Test	Class 2	2San™ COVID-19 Rapid Self-Test, Hough™ COVID-19 Antigen Home Test, WELLlife™ COVID-19 Antigen Home Test, WELLlife™ COVD-19 Antigen Test	2024	5
Reagent, Occult Blood	Class 2	TOPAZ FIT iFOB Immunochemical Fecal Occult Blood Test, Preview iFOB Immunochemical Fecal Occult Blood Test (FIT), Colonox™ FIT, WELLlife™ iFOB Immunochemical Fecal Occult Blood Test, INDICAID™ iFOB IMMUNOCHEMICAL FECAL OCCULT BLOOD RAPID TEST, 2San™ Colorectal Health Test (immunochemical fecal occult blood test) and 6 more	2017	5
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings	Class 2	WELLlife™ COVID-19 Antigen Test Rx, Clarity COVID-19 Antigen Test	2025	3
System, Test, Human Chorionic Gonadotropin	Class 2	Independent Medical Co-op Inc., IMCO HCG Combo Cassettes, One Step HCG Urine/Serum Test, Toptolife™ hCG Urine/Serum Combo Pregnancy Test	2009	3
Test System, Nicotine, Cotinine, Metabolites	Class 1	SAFElife™ T-Dip Cotinine (COT) Urine Test Panel, SAFElife™ T-Swab Cotinine (COT) Oral Fluid Test, PRIME SCREEN® Single Panel Urine Test Cotinine (COT)	2019	11
Test, Amphetamine, Employment And Insurance Testing, Exempt	Class 2	iSCREEN™ Oral Fluid Test Drug Screen Swab, SAFElife™ Multi-Panel Rapid Hair Test, STATSWAB® III Oral Fluid Drug Test, SAFElife™ T-Square Multi-Drug Oral Fluid Test, iSCREEN™ ORAL FLUID TEST DRUG SCREEN CUBE, SAFElife™ T-Swab Multi-Drug Oral Fluid Test and 1 more	2018	11
Test, Amphetamine, Over The Counter	Class 2	Mintegrity® Multi-Panel Urine Test, Easy@Home® Multi-Drug Screen Test, EDOAP-144, SAFElife™ T-Dip Nortriptyline (TCA) Urine Test Panel, SAFElife™ T-Dip Oxazepam (BZO) Urine Test Panel Rx, SAFElife™ T-Dip Secobarbital (BAR) Urine Test Panel Rx, SAFElife™ T-Dip Oxycodone (OXY) Urine Test Panel and 99 more	2018	16
Test, Barbiturate, Employment And Insurance Testing, Exempt	Class 2	Prime Screen One Step Multi-Drug Oral Fluid Test, STATSWAB® III Oral Fluid Drug Test, iSCREEN™ ORAL FLUID TEST DRUG SCREEN CUBE, SAFElife™ T-Square Multi-Drug Oral Fluid Test, SAFElife™ T-Swab Multi-Drug Oral Fluid Test	2018	11
Test, Barbiturate, Over The Counter	Class 2	Mintegrity® Multi-Panel Urine Test, Easy@Home® Multi-Drug Screen Test, EDOAP-144, SAFElife™ T-Dip Nortriptyline (TCA) Urine Test Panel, SAFElife™ T-Dip Oxazepam (BZO) Urine Test Panel Rx, SAFElife™ T-Dip Secobarbital (BAR) Urine Test Panel Rx, SAFElife™ T-Dip Oxycodone (OXY) Urine Test Panel and 99 more	2018	16
Test, Benzodiazepine, Employment And Insurance Testing, Exempt	Class 2	SAFElife™ Multi-Panel Rapid Hair Test	2018	11
Test, Benzodiazepine, Over The Counter	Class 2	Mintegrity® Multi-Panel Urine Test, Easy@Home® Multi-Drug Screen Test, EDOAP-144, SAFElife™ T-Dip Nortriptyline (TCA) Urine Test Panel, SAFElife™ T-Dip Oxazepam (BZO) Urine Test Panel Rx, SAFElife™ T-Dip Secobarbital (BAR) Urine Test Panel Rx, SAFElife™ T-Dip Oxycodone (OXY) Urine Test Panel and 99 more	2018	16
Test, Cannabinoid, Employment And Insurance Testing, Exempt	Class 2	iSCREEN™ ORAL FLUID TEST DRUG SCREEN CUBE, iSCREEN™ Oral Fluid Test Drug Screen Swab, SAFElife™ T-Square Multi-Drug Oral Fluid Test, SAFElife™ T-Swab Multi-Drug Oral Fluid Test, Prime Screen® One Step Multi-Drug Oral Fluid Test, STATSWAB® III Oral Fluid Drug Test	2018	12
Test, Cannabinoid, Over The Counter	Class 2	Mintegrity® Multi-Panel Urine Test, Easy@Home® Multi-Drug Screen Test, EDOAP-144, SAFElife™ T-Dip Nortriptyline (TCA) Urine Test Panel, SAFElife™ T-Dip Oxazepam (BZO) Urine Test Panel Rx, SAFElife™ T-Dip Secobarbital (BAR) Urine Test Panel Rx, SAFElife™ T-Dip Oxycodone (OXY) Urine Test Panel and 99 more	2018	16
Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	Class 2	STATSWAB® III Oral Fluid Drug Test, SAFElife™ T-Square Multi-Drug Oral Fluid Test, iSCREEN™ ORAL FLUID TEST DRUG SCREEN CUBE, iSCREEN™ Oral Fluid Test Drug Screen Swab, Prime Screen® One Step Multi-Drug Oral Fluid Test, SAFElife™ Multi-Panel Rapid Hair Test and 1 more	2018	12
Test, Cocaine And Cocaine Metabolites, Over The Counter	Class 2	Mintegrity® Multi-Panel Urine Test, Easy@Home® Multi-Drug Screen Test, EDOAP-144, SAFElife™ T-Dip Nortriptyline (TCA) Urine Test Panel, SAFElife™ T-Dip Oxazepam (BZO) Urine Test Panel Rx, SAFElife™ T-Dip Secobarbital (BAR) Urine Test Panel Rx, SAFElife™ T-Dip Oxycodone (OXY) Urine Test Panel and 99 more	2018	16
Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Class 1	Ovarian Reserve Screening Test, HORMONElife™ Ultra Accurate FSH Test Strip	2023	30
Test, Luteinizing Hormone (Lh), Over The Counter	Class 1	Ovulation Tests, Ovulation Test, Mintegrity® Ovulation Test, Easy@Home Ovulation Test Kit (Strip), Modern Fertility Ovulation Predictor Test, One Step Ovulation Test and 14 more	2016	38
Test, Methadone, Employment And Insurance Testing, Exempt	Class 2	SAFElife™ T-Swab Multi-Drug Oral Fluid Test, Prime Screen One Step Multi-Drug Oral Fluid Test, STATSWAB® III Oral Fluid Drug Test, SAFElife™ T-Square Multi-Drug Oral Fluid Test, iSCREEN™ ORAL FLUID TEST DRUG SCREEN CUBE	2018	11
Test, Methadone, Over The Counter	Class 2	Mintegrity® Multi-Panel Urine Test, Easy@Home® Multi-Drug Screen Test, EDOAP-144, SAFElife™ T-Dip Nortriptyline (TCA) Urine Test Panel, SAFElife™ T-Dip Oxazepam (BZO) Urine Test Panel Rx, SAFElife™ T-Dip Secobarbital (BAR) Urine Test Panel Rx, SAFElife™ T-Dip Oxycodone (OXY) Urine Test Panel and 99 more	2018	17
Test, Methamphetamine, Employment And Insurance Testing, Exempt	Class 2	iSCREEN™ Oral Fluid Test Drug Screen Swab, STATSWAB® III Oral Fluid Drug Test, SAFElife™ T-Square Multi-Drug Oral Fluid Test, iSCREEN™ ORAL FLUID TEST DRUG SCREEN CUBE, SAFElife™ Multi-Panel Rapid Hair Test, Prime Screen® One Step Multi-Drug Oral Fluid Test and 1 more	2018	13
Test, Methamphetamine, Over The Counter	Class 2	Mintegrity® Multi-Panel Urine Test, Easy@Home® Multi-Drug Screen Test, EDOAP-144, SAFElife™ T-Dip Nortriptyline (TCA) Urine Test Panel, SAFElife™ T-Dip Oxazepam (BZO) Urine Test Panel Rx, SAFElife™ T-Dip Secobarbital (BAR) Urine Test Panel Rx, SAFElife™ T-Dip Oxycodone (OXY) Urine Test Panel and 99 more	2018	16
Test, Opiates, Employment And Insurance Testing, Exempt	Class 2	iSCREEN™ Oral Fluid Test Drug Screen Swab, SAFElife™ T-Swab Multi-Drug Oral Fluid Test, SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel, SAFElife™ T-Square Multi-Drug Oral Fluid Test, STATSWAB® III Oral Fluid Drug Test, SAFElife™ Multi-Panel Rapid Hair Test and 2 more	2018	12
Test, Opiates, Over The Counter	Class 2	UA Fentanyl Urine Test (Dip Card), SAFElife™ Fentanyl Urine Home Test (Dip Card), UA Fentanyl Urine Test (Cassette), SAFElife™ Fentanyl Urine Home Test (Cassette), SAFElife™ Fentanyl Urine Test (Dip Card), SAFElife™ Fentanyl Urine Test (Cassette) and 105 more	2018	18
Test, Propoxyphene, Over The Counter	Class 2	Mintegrity® Multi-Panel Urine Test, Easy@Home® Multi-Drug Screen Test, EDOAP-144, SAFElife™ T-Dip Nortriptyline (TCA) Urine Test Panel, SAFElife™ T-Dip Oxazepam (BZO) Urine Test Panel Rx, SAFElife™ T-Dip Secobarbital (BAR) Urine Test Panel Rx, SAFElife™ T-Dip Oxycodone (OXY) Urine Test Panel and 99 more	2018	16
Test, Tricyclic Antidepressants, Over The Counter	Class 2	Mintegrity® Multi-Panel Urine Test, Easy@Home® Multi-Drug Screen Test, EDOAP-144, SAFElife™ T-Dip Nortriptyline (TCA) Urine Test Panel, SAFElife™ T-Dip Oxazepam (BZO) Urine Test Panel Rx, SAFElife™ T-Dip Secobarbital (BAR) Urine Test Panel Rx, SAFElife™ T-Dip Oxycodone (OXY) Urine Test Panel and 99 more	2018	16
Visual, Pregnancy Hcg, Prescription Use	Class 2	HORMONElife™ Pregnancy Test Strip, HORMONElife™ Fertility Combination Tests (HORMONElife™ Pregnancy Test Strip), HORMONElife™ Pregnancy Home Test Midstream, HORMONElife™ Pregnancy Test Cassette Rx, Easy At Home Medical LLC Easy@Home Early Pregnancy Test (strip), One Step HCG Urine Test and 32 more	2008	16

Clearances

510(k) clearances naming Guangzhou Wondfo Biotech Co., Ltd. or its listings
Clearance	Decision date	Product code	Route	Held by
K260065	2026-04-28	NFT	Traditional	This company
K252550	2025-11-18	NFT	Traditional	This company
K251289	2025-10-22	QVF	Dual Track	This company
K241317	2024-09-30	QYT	Traditional	This company
K241741	2024-07-16	NGL	Traditional	This company
K202567	2020-09-25	NFT	Traditional	This company
K182701	2018-12-03	NFT	Traditional	This company
K173229	2018-03-12	LCX	Traditional	This company
K162333	2017-05-14	KHE	Traditional	This company
K161214	2016-06-27	DIO	Traditional	This company
K152495	2015-11-23	JXN	Traditional	This company
K150022	2015-08-07	LCX	Traditional	This company
K151478	2015-07-01	DJG	Special	This company
K150602	2015-04-07	DNK	Traditional	This company
K150179	2015-02-25	DJG	Traditional	This company
K143535	2015-01-13	DIS	Traditional	This company
K142609	2014-12-18	LFG	Traditional	This company
K142044	2014-08-25	LCM	Traditional	This company
K141532	2014-07-14	DKZ	Traditional	This company
K140089	2014-04-08	DJG	Traditional	This company
K133968	2014-02-25	DKZ	Special	This company
K133343	2014-01-31	GTY	Traditional	This company
K132630	2013-09-27	DJC	Traditional	This company
K131754	2013-07-31	DIO	Traditional	This company
K131232	2013-05-31	DJR	Traditional	This company
K130665	2013-04-09	DJG	Special	This company
K130055	2013-02-14	DJG	Traditional	This company
K122961	2012-12-21	DKZ	Traditional	This company
K122904	2012-11-15	DKZ	Special	This company
K121987	2012-08-01	DKZ	Traditional	This company
K121557	2012-07-25	LDJ	Traditional	This company
K121166	2012-05-08	DIO	Special	This company
K113624	2012-03-12	DJG	Traditional	This company
K112071	2011-09-23	DIO	Traditional	This company
K112236	2011-09-19	LAF	Traditional	This company
K112395	2011-09-09	LFG	Traditional	This company
K112310	2011-09-08	DJG	Traditional	This company
K111560	2011-07-15	DKZ	Traditional	This company
K110182	2011-05-20	LDJ	Traditional	This company
K093175	2010-08-25	DJG	Traditional	This company
K072500	2009-04-21	DHA	Traditional	This company
K050024	2005-11-17	DIS	Traditional	This company
K043443	2005-04-08	LCX	Traditional	This company

Recalls

3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls naming Guangzhou Wondfo Biotech Co., Ltd.
Initiated	FDA class	Root cause	Reason	Quantity
2018-05-18	Class II	Nonconforming Material/Component	GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collection device could cause the foam tip to become dislodged in t	50,000 units
2018-05-18	Class II	Nonconforming Material/Component	GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collection device could cause the foam tip to become dislodged in t	60,000 units
2018-05-18	Class II	Nonconforming Material/Component	GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collection device could cause the foam tip to become dislodged in t	16,000 units

From the Company

Published by the company on its own website, not by the FDA.

Information published by Guangzhou Wondfo Biotech Co., Ltd.
Founded	1992
Employees	3000+
Main products	colloidal gold diagnostics, immunofluorescence tests, chemiluminescence assays, molecular diagnostics, pathology tests
Export markets	150+ countries

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Guangzhou Fame Medical Co., Ltd.	1
Guangzhou Harley Commodity Company Limited	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

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