BEUDAMED
    FDA Registration Active 🇺🇸 United States

    WONDFO USA CO., LTD.

    Reg #: 3007606081 · FEI: 3007606081 · Expires 2026
    View on FDA
    Products
    44
    Proprietary Names
    203
    Establishment Types
    1
    Classifications
    44

    Registration Details

    Registration Name
    WONDFO USA CO., LTD.
    Registration Number
    3007606081
    FEI Number
    3007606081
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    890 Remington Blvd
    City
    Bolingbrook
    State
    IL
    ZIP
    60440
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121557

    Owner / Operator

    Firm Name
    Wondfo USA Co., Ltd.
    Operator Number
    10028951
    Address
    890 REMINGTON BLVD
    City
    Bolingbrook
    State
    IL
    Postal Code
    60440
    Country
    US
    Correspondent
    Kunyuan Mao

    Products

    Device Name Product Code
    Test, Benzodiazepine, Employment And Insurance Testing, Exempt PUZ
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Propoxyphene JXN
    Test, Opiates, Employment And Insurance Testing, Exempt PVH
    Container, Specimen, Non-Sterile NNI
    Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA
    Antigens, All Groups, Streptococcus Spp. GTY
    Test, Barbiturate, Over The Counter PTH
    Test, Opiates, Over The Counter NGL
    Test, Propoxyphene, Over The Counter QBF
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Methadone, Over The Counter PTG
    Test, Methamphetamine, Over The Counter NGG
    Test, Cannabinoid, Over The Counter NFW
    Test, Benzodiazepine, Over The Counter NFV
    Enzyme Immunoassay, Phencyclidine LCM
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Amphetamine, Over The Counter NFT
    Test, Amphetamine, Employment And Insurance Testing, Exempt PUX
    System, Test, Human Chorionic Gonadotropin DHA
    Test, Methadone, Employment And Insurance Testing, Exempt PVE
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Visual, Pregnancy Hcg, Prescription Use JHI
    Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings QVF
    Test, Cannabinoid, Employment And Insurance Testing, Exempt PVJ
    Kit, Direct Antigen, Positive Control MJZ
    Enzyme Immunoassay, Amphetamine DKZ
    Enzyme Immunoassay, Benzodiazepine JXM
    Enzyme Immunoassay, Opiates DJG
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Gas Chromatography, Methamphetamine LAF
    Enzyme Immunoassay, Barbiturate DIS
    Fluorometer, For Clinical Use KHO
    Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method DIC
    Container, Specimen Mailer And Storage, Non-Sterile NNK
    Covid-19 Multi-Analyte Antigen Device QMN
    Test System, Nicotine, Cotinine, Metabolites MRS
    Immunoassay, Pregnanediol Glucuronide, Over The Counter QKE
    Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt PVA
    Test, Methamphetamine, Employment And Insurance Testing, Exempt PVD
    Reagent, Occult Blood KHE
    Over-The-Counter Covid-19 Antigen Test QYT
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Test, Barbiturate, Employment And Insurance Testing, Exempt PUY

    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 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 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 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 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 SAFElife™ F-Cup Multi-Drug Urine Test Cup Dx SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx iSCREEN™ Urine Test Dx Drug Screen Square Cup SAFElife™ S-Cup Multi-Drug Urine Test Cup Dx One Step Saliva Alcohol Test Strip PRIME SCREEN® Saliva Alcohol Test Strip TopazFIT Collection Kits WELLlife™ COVID-19 / Influenza A&B Test WELLlife™ COVID-19 / Influenza A&B Home Test SAFElife™ T-Dip Cotinine (COT) Urine Test Panel SAFElife™ T-Swab Cotinine (COT) Oral Fluid Test HORMONElife™ PdG Urine Test Strip Wondfo® PdG Urine Test SAFElife™ Fentanyl Urine Test (Cassette) SAFElife™ Fentanyl Urine Home Test (Dip Card) SAFElife™ Fentanyl Urine Home Test (Cassette) UA Fentanyl Urine Test (Dip Card) SAFElife™ Fentanyl Urine Test (Dip Card) UA Fentanyl Urine Test (Cassette) Toptolife™ iFOB Immunochemical Fecal Occult Blood Test WELLlife™ iFOB Immunochemical Fecal Occult Blood Test 2San™ Colorectal Health Test (immunochemical fecal occult blood test) INDICAID™ iFOB IMMUNOCHEMICAL FECAL OCCULT BLOOD RAPID TEST RX Aydmed Immunochemical Fecal Occult Blood (iFOB) Test INDICAID™ iFOB IMMUNOCHEMICAL FECAL OCCULT BLOOD RAPID TEST EZCHECK® At-home iFOB Test Immunochemical Fecal Occult Blood Test(FIT) Test Yourself @ Home™ Immunochemical Fecal Occult Blood Test COLONOX™ FIT Hough™ COVID-19 Antigen Home Test WELLlife™ COVD-19 Antigen Test WELLlife™ COVID-19 Antigen Home Test 2San™ COVID-19 Rapid Self-Test HORMONElife™ Fertility Combination Tests (HORMONElife™ Ovulation Test Strip) Ovulation Tests Easy@Home Ovulation Test Kit (Strip) Easy@Home Ovulation Test (Midstream) INDICAID™ OVULATION TEST STRIP Premom Ovulation Test, PMS2-S PREGABLE OVULATION & PREGNANCY TEST KIT (PREGABLE OVULATION TEST) HORMONElife™ Ultra Accurate Ovulation Test Strip HORMONElife™ Ovulation Test Strip Micro Distributing II Ltd. STATCUPII One Step Drug Test Cup Micro Distributing II Ltd. FASTEST LABS One Step Drug Test Cup Easy Healthcare Corporation Areta Drug Test Cup easy@Home® Multi-Drug Screen Test

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198