Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007606081

FEI Number

3007606081

Entity Name

WONDFO USA CO., LTD.

City/State/Country

Bolingbrook, IL, US

Establishment Address

890 Remington Blvd, Bolingbrook, IL 60440, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Wondfo USA Co., Ltd. (Owner Number: 10028951)

Owner / Operator Contact Address

890 REMINGTON BLVD, Bolingbrook, IL 60440, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111206

PMA Number

N/A

All Registered Proprietary Names

SAFElife Multi-Panel Rapid Hair Test Easy@Home Single Drug Screen Test (Cannabinoids Urine Test), EDTH-114 Easy@Home Single Drug Screen Test (Cannabinoids Urine Test) iSCREEN ORAL FLUID TEST DRUG SCREEN CUBE SAFElife T-Square Multi-Drug Oral Fluid Test Prime Screen® One Step Multi-Drug Oral Fluid Test SAFElife T-Dip Fentanyl (FTY) Urine Test Panel iSCREEN ORAL FLUID TEST DRUG SCREEN SWAB SAFElife T-Swab Multi-Drug Oral Fluid Test STATSWAB® III Oral Fluid Drug Test SAFElife Multi-Panel Rapid Hair Test Vacu Lid HORMONElife Ultra Accurate FSH Test Strip Ovarian Reserve Screening Test Toptolife Strep A Test Preview® Strep A Test Kit Easy Healthcare Corporation, Easy@Home Multi-Drug Screen Test ONCORE DETOX Single Drug Dip Card (THC) Easy@Home® Multi-Drug Screen Test, EDOAP-254 SAFElife T-Dip Buprenorphine (BUP) Urine Test Panel SAFElife T-Dip Multi-Drug Urine Test Panel Rx SAFElife T-Dip Cocaine (COC150) Urine Test Panel SAFElife T-Dip Secobarbital (BAR) Urine Test Panel SAFElife T-Dip Methadone (MTD) Urine Test Panel Rx SAFElife T-Dip Buprenorphine (BUP) Urine Test Panel Rx SAFElife T-Dip Propoxyphene (PPX) Urine Test Panel Easy@Home® Multi-Drug Screen Test, EDOAP-754 SAFElife T-Dip Cocaine (COC) Urine Test Panel Easy@Home® Single Drug Screen Test Multi-Drug Screen Test SAFElife T-Dip Amphetamine (AMP) Urine Test Panel Rx SAFElife T-Dip Methadone (MTD) Urine Test Panel SAFElife T-Dip Single Drug Urine Test Panel PRIME SCREEN® Multi-Panel Urine Test SAFElife T-Dip Morphine (MOP) Urine Test Panel SAFElife T-Dip Cocaine (COC150) Urine Test Panel Rx SAFElife T-Dip Oxycodone (OXY) Urine Test Panel SAFElife T-Dip Nortriptyline (TCA) Urine Test Panel SAFElife T-Dip Propoxyphene (PPX) Urine Test Panel Rx Easy@Home® Multi-Drug Screen Test, EDOAP-1124 SAFElife T-Dip Multi-Drug Urine Test Panel ONCORE DETOX Single Drug Dip Card (COC) PRIME SCREEN® Single Panel Urine Test Cocaine (COC) SAFElife T-Dip Amphetamine (AMP500) Urine Test Panel Rx Multi-Drug Urine Test Panel SAFElife T-Dip Cannabinoids (THC) Urine Test Panel Rx SAFElife T-Dip Oxazepam (BZO) Urine Test Panel Rx SAFElife T-Dip Methamphetamine (MET/mAMP) Urine Test Panel Rx Single Drug Urine Test Panel ONCORE DETOX Single Drug Dip Card (OPI) SAFElife T-Dip Morphine (OPI) Urine Test Panel Rx ONCORE DETOX Single Drug Dip Card (MET/mAMP) SAFElife T-Dip Phencyclidine (PCP) Urine Test Panel Single Drug Screen Test Easy@Home® Multi-Drug Screen Test, EDOAP-6125B SAFElife T-Dip Methylenedioxymethamphetamine (MDMA) Urine Test Panel Rx PRIME SCREEN® Single Panel Urine Test Cannabinoids (THC) PRIME SCREEN® Single Panel Urine Test Oxazepam (BZO) SAFElife T-Dip Amphetamine (AMP) Urine Test Panel SAFElife T-Dip Cannabinoids (THC) Urine Test Panel ONCORE DETOX Multi-Drug Dip Card ONCORE DETOX Single Drug Dip Card (AMP) SAFElife T-Dip Methamphetamine (MET/mAMP) Urine Test Panel SAFElife T-Dip Secobarbital (BAR) Urine Test Panel Rx SAFElife T-Dip Nortriptyline (TCA) Urine Test Panel Rx iSCREEN URINE TEST DX DRUG SCREEN DIP CARD Easy@Home Multi-Drug Screen Test, EDOAP-4104 Easy@Home® Multi-Drug Screen Test, EDOAP-264 SAFElife T-Dip Cocaine (COC) Urine Test Panel Rx SAFElife T-Dip Oxycodone (OXY) Urine Test Panel Rx Easy@Home® Multi-Drug Screen Test, EDOAP-3104 SAFElife T-Dip Methylenedioxymethamphetamine (MDMA) Urine Test Panel SAFElife T-Dip Morphine (OPI) Urine Test Panel Easy@Home® Multi-Drug Screen Test, EDOAP-7104 SAFElife T-Dip Morphine (MOP) Urine Test Panel Rx SAFElife T-Dip Methamphetamine (MET500/mAMP500) Urine Test Panel Rx Easy@Home® Multi-Drug Screen Test, EDOAP-654 SAFElife T-Dip Phencyclidine (PCP) Urine Test Panel Rx SAFElife T-Dip Amphetamine (AMP500) Urine Test Panel Easy@Home® Multi-Drug Screen Test, EDOAP-144 SAFElife T-Dip Oxazepam (BZO) Urine Test Panel SAFElife T-Dip Methamphetamine (MET500/mAMP500) Urine Test Panel Easy@Home Multi-Drug Screen Test, EDOAP-7125 SAFElife Multi-Panel Rapid Hair Test iSCREEN ORAL FLUID TEST DRUG SCREEN CUBE SAFElife T-Square Multi-Drug Oral Fluid Test SAFElife T-Swab Multi-Drug Oral Fluid Test iSCREEN ORAL FLUID TEST DRUG SCREEN SWAB Prime Screen® One Step Multi-Drug Oral Fluid Test STATSWAB® III Oral Fluid Drug Test Toptolife hCG Urine/Serum Combo Pregnancy Test One Step HCG Urine/Serum Test Independent Medical Co-op Inc., IMCO HCG Combo Cassettes 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 Dealmed HCG Pregnancy Test Strip INDICAID HCG PREGNANCY TEST STRIP HORMONElife Pregnancy Home Test Midstream UA One Step HCG Urine Test Clarity MIDSTREAM PREGNANCY TEST HORMONElife Pregnancy Test Strip HORMONElife Pregnancy Test Cassette Rx PREGABLE OVULATION & PREGNANCY TEST KIT (PREGABLE PREGNANCY TEST) HORMONElife Fertility Combination Tests (HORMONElife Pregnancy Test Strip) T-Cup Multi-Drug Urine Test Cup Micro Distributing II, Ltd, STAT Cup One Step Drug Test Guangzhou Wondfo Biotech Co., Wondfo VacuLid Multi-Drug Urine Test Cup Areta Multi-Drug Test Cup RST Home Drug Test Kit Cup (Urine) Areta Multi-Drug Test Cup, ACDOA-754 Easy@Home Drug Test Cup, ECDOA-7124 IDT Multi Drug Urine Test Cup T-Cup® Compact Multi-Drug Urine Test Cup Areta Multi-Drug Test Cup, ACDOA-6125B PRIME SCREEN® Multi-Drug Urine Test Cup CheckNow Multi - Drug Urine Test Cup T-Cup® Multi-Drug Urine Test Cup Easy@Home Drug Test Cup, ECDOA-254 iSCREEN URINE TEST DRUG SCREEN SQUARE CUP iSCREEN URINE TEST DX DRUG SCREEN COMPACT ROUND CUP easy@Home Drug Test Cup, ECDOA3-6125B Easy@Home Drug Test Cup, ECDOA-1144A3 Areta Multi-Drug Test Cup, ACDOA-264 Easy@Home Drug Test Cup, ECDOA-6125B SAFElife S-Cup Multi-Drug Urine Test Cup QTEST Multi-Drug Urine Test Compact Cup BluRapids® MULTI-DRUG TEST CUP SAFElife C-Cup Multi-Drug Urine Test Cup 2SAN Home Drug Test Kit Areta Multi-Drug Test Cup, ACDOA-1144 Drug Test Cup INDICAID Multi-Drug Urine Test Cup Medline Drug Test Cup easy@Home® Drug Test Cup Clarity Multi-Drug Urine Test Cup (Urine) SAFElife T-Cup Multi-Drug Urine Test Cup SAFElife F-Cup Multi-Drug Urine Test Cup T-Cup Compact Multi-Drug Urine Test Cup, CDOA-6125 iSCREEN URINE TEST DX DRUG SCREEN SQUARE CUP iSCREEN URINE TEST DX DRUG SCREEN ROUND CUP UA Multi-Drug Urine Test Cup Multi-Drug Test Cup IDT Multi Drug Urine Test Compact Cup HORMONElife Early Result Pregnancy Test Midstream HORMONElife Early Result Pregnancy Test Strip Rx EARLY PREGNANCY TESTS INDICAID HCG EARLY RESULT PREGNANCY TEST STRIP Wondfo® HCG Early Result Pregnancy Test (Midstream) BABYlife Early Result Pregnancy Test Early Results Pregnancy Tests HORMONElife Early Result Pregnancy Test Strip Mintegrity® HCG Early Result Pregnancy Test WELLlife COVID-19 Antigen Test Rx SAFElife T-Swab Multi-Drug Oral Fluid Test iSCREEN ORAL FLUID TEST DRUG SCREEN CUBE STATSWAB® III Oral Fluid Drug Test Prime Screen® One Step Multi-Drug Oral Fluid Test SAFElife T-Square Multi-Drug Oral Fluid Test iSCREEN ORAL FLUID TEST DRUG SCREEN SWAB PRIME SCREEN® Marijuana (THC) Urine Test Strip SAFElife Cannabinoids (THC) Urine Test PRIME SCREEN® Cannabinoids (THC) Urine Test Strip WELLlife COVID-19 Antigen Test Rx Control Kit WELLlife Influenza A&B Test Control Kit WELLlife COVID-19 / Influenza A&B Antigen Test Control Kit QuickVue Influenza+SARS Test Control Kit INDICAID COVID-19 / INFLUENZA A&B ANTIGEN TEST CONTROL KIT Easy@Home Multi-Drug Urine Test Panel Easy@Home Multi-Drug Urine Test Cup Multi-Drug Urine Test Cup, Multi-Drug Urine Test Panel SAFElife Fentanyl Urine Detection Kit SAFElife D1 Fluorescence Immunoassay Analyzer SAFElife C-Cup Multi-Drug Urine Test Cup Dx PRIME SCREEN® Multi-Drug Urine Test Cup SAFElife F-Cup Multi-Drug Urine Test Cup Dx SAFElife T-Cup Multi-Drug Urine Test Cup Dx SAFElife T-Cup Multi-Drug Urine Test Cup SAFElife S-Cup Multi-Drug Urine Test Cup iSCREEN Urine Test Dx Drug Screen Square Cup SAFElife C-Cup Multi-Drug Urine Test Cup SAFElife F-Cup Multi-Drug Urine Test Cup SAFElife S-Cup Multi-Drug Urine Test Cup Dx One Step Saliva Alcohol Test Strip PRIME SCREEN® Saliva Alcohol Test Strip

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUZ	Test, Benzodiazepine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3170	2020-12-24
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2013-01-28
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2013-01-28
PVH	Test, Opiates, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3650	2020-12-24
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2020-12-24
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2024-01-16
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2018-05-05
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2020-12-24
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2020-12-24
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2020-12-24
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2020-12-24
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2020-12-24
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2020-12-24
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2020-12-24
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2020-12-24
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2020-12-24
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2020-12-24
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2020-12-24
PUX	Test, Amphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3100	2020-12-24
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2020-12-24
PVE	Test, Methadone, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3620	2020-12-24
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2009-05-29
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2009-05-29
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2020-12-24
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2020-12-24
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2020-12-24
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2020-12-24
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2020-12-24
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2020-12-24
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2020-12-24
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2020-12-24
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2020-12-24
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2020-12-24
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2020-12-24
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2018-05-05
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2018-05-05
QVF	Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings	Microbiology	Class 2	866.3982	2025-12-01
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3870	2020-12-24
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2013-01-28
MJZ	Kit, Direct Antigen, Positive Control	Clinical Chemistry	Class 1	862.1660	2025-09-10
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2013-12-04
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2013-12-04
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2013-12-04
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2013-12-04
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2013-12-04
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2013-12-04
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2013-12-04
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2013-12-04
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2023-08-03
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2023-08-03
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2025-12-01
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2025-12-01
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2025-12-01
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2025-12-01
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2025-12-01
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2025-12-01
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2025-12-01
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2025-12-01
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2025-12-01
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2025-12-01
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2025-12-01
DIC	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	Clinical Toxicology	Class 2	862.3040	2020-12-24

Official Correspondent

Kunyuan Mao

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Wondfo USA Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016252795	Wondfo USA Co., Ltd.	San Diego, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K110182	Guangzhou Wondfo Biotech Co., Ltd.	CANNABINOIDS URINE TEST	2011-05-20
K121557	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST	2012-07-25
K920418	Instrumentation Laboratory CO	IL TEST CANNABINOID, 35282	1992-02-27
K152495	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo Propoxyphene Urine Test	2015-11-23
K133343	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO RAPID STREP A TEST	2014-01-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-06	Nichols Institute Diagnostics	2	Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay Cartridges (Catalog #62-7052)
Z-0007-06	Nichols Institute Diagnostics	2	Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Z-0006-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007606081. Last updated year: 2026. Please use registration number 3007606081 when referencing this establishment in official correspondence.