BEUDAMED
    FDA Registration Active 🇨🇳 China

    GUANGZHOU WONDFO BIOTECH CO., LTD.

    Reg #: 3023322455 · FEI: 3023322455 · Expires 2026
    View on FDA
    Products
    42
    Proprietary Names
    248
    Establishment Types
    1
    Classifications
    42

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    Registration Details

    Registration Name
    GUANGZHOU WONDFO BIOTECH CO., LTD.
    Registration Number
    3023322455
    FEI Number
    3023322455
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 268, Shenzhou Road, Huangpu District
    City
    Guangzhou Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K111206

    Owner / Operator

    Firm Name
    GUANGZHOU WONDFO BIOTECH CO., LTD.
    Operator Number
    9064561
    Address
    No.8 lizhishan Road, Science City, Huangpu District, 510663
    City
    GUANGZHOU
    State
    Guangdong
    Postal Code
    510663
    Country
    CN
    Correspondent
    Jihua - Wang

    US Agent

    Business Name
    LSI International Inc.
    Contact Name
    Joe Shia
    Address
    504 East Diamond Ave., Suite H
    City
    Gaithersburg
    State
    MD
    ZIP
    20877
    Country
    US
    Email
    [email protected]
    Phone
    240 5057880

    Products

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

    Proprietary Names

    iSCREEN™ Oral Fluid Test Drug Screen Swab SAFElife™ T-Swab Multi-Drug Oral Fluid Test SAFElife™ Multi-Panel Rapid Hair 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 iSCREEN™ ORAL FLUID TEST DRUG SCREEN SWAB STATSWAB® III Oral Fluid Drug Test One Step Saliva Alcohol Test Strip PRIME SCREEN® Saliva Alcohol Test Strip WELLlife™ COVID-19 Antigen Test Rx Prime Screen One Step Multi-Drug Oral Fluid Test PRIME SCREEN® One Step Multi-Drug Oral Fluid Test SAFElife™ T-Dip Methamphetamine (MET/mAMP) Urine Test Panel SAFElife™ T-Dip Multi-Drug Urine Test Panel Easy@Home® Multi-Drug Screen Test, EDOAP-754 SAFElife™ T-Dip Methadone (MTD) Urine Test Panel Rx Easy@Home® Multi-Drug Screen Test, EDOAP-144 SAFElife™ T-Dip Oxycodone (OXY) Urine Test Panel Rx SAFElife™ T-Dip Methamphetamine (MET/mAMP) Urine Test Panel Rx SAFElife™ T-Dip Phencyclidine (PCP) Urine Test Panel Rx SAFElife™ T-Dip Methamphetamine (MET500/mAMP500) Urine Test Panel Rx ONCORE DETOX Single Drug Dip Card (COC) Easy@Home® Multi-Drug Screen Test, EDOAP-254 SAFElife™ T-Dip Single Drug Urine Test Panel SAFElife™ T-Dip Methylenedioxymethamphetamine (MDMA) Urine Test Panel Rx SAFElife™ T-Dip Amphetamine (AMP) Urine Test Panel Rx Single Drug Urine Test Panel PRIME SCREEN® Multi-Panel Urine Test SAFElife™ T-Dip Cannabinoids (THC) Urine Test Panel Rx ONCORE DETOX Single Drug Dip Card (OPI) Multi-Drug Screen Test PRIME SCREEN® Single Panel Urine Test Cocaine (COC) Multi-Drug Urine Test Panel SAFElife™ T-Dip Cannabinoids (THC) Urine Test Panel SAFElife™ T-Dip Oxazepam (BZO) Urine Test Panel Rx SAFElife™ T-Dip Morphine (OPI) Urine Test Panel Rx SAFElife™ T-Dip Phencyclidine (PCP) Urine Test Panel SAFElife™ T-Dip Secobarbital (BAR) Urine Test Panel Rx Easy Healthcare Corporation, Easy@Home Multi-Drug Screen Test Easy@Home Multi-Drug Screen Test, EDOAP-7125 SAFElife™ T-Dip Multi-Drug Urine Test Panel Rx SAFElife™ T-Dip Amphetamine (AMP) Urine Test Panel SAFElife™ T-Dip Morphine (MOP) Urine Test Panel SAFElife™ T-Dip Buprenorphine (BUP) Urine Test Panel Rx Easy@Home® Multi-Drug Screen Test, EDOAP-065 SAFElife™ T-Dip Methylenedioxymethamphetamine (MDMA) Urine Test Panel SAFElife™ T-Dip Cocaine (COC150) Urine Test Panel Rx SAFElife™ T-Dip Methadone (MTD) Urine Test Panel SAFElife™ T-Dip Amphetamine (AMP500) Urine Test Panel SAFElife™ T-Dip Nortriptyline (TCA) Urine Test Panel ONCORE DETOX Single Drug Dip Card (THC) SAFElife™ T-Dip Propoxyphene (PPX) Urine Test Panel Prime Screen® Multi-Panel Urine Test Mintegrity® Single-Panel Urine Test (Cannabinoids (THC)) Easy@Home® Multi-Drug Screen Test, EDOAP-7104 SAFElife™ T-Dip Oxycodone (OXY) Urine Test Panel SAFElife™ T-Dip Oxazepam (BZO) Urine Test Panel SAFElife™ T-Dip Nortriptyline (TCA) Urine Test Panel Rx Mintegrity® Multi-Panel Urine Test SAFElife™ T-Dip Cocaine (COC) Urine Test Panel Rx iSCREEN™ URINE TEST DX DRUG SCREEN DIP CARD SAFElife™ T-Dip Secobarbital (BAR) Urine Test Panel Easy@Home® Multi-Drug Screen Test, EDOAP-3104 PRIME SCREEN® Single Panel Urine Test Oxazepam (BZO) Easy@Home® Multi-Drug Screen Test, EDOAP-1124 PRIME SCREEN® Single Panel Urine Test Cannabinoids (THC) SAFElife™ T-Dip Morphine (OPI) Urine Test Panel Easy@Home® Multi-Drug Screen Test, EDOAP-654 Easy@Home® Multi-Drug Screen Test, EDOAP-6125B SAFElife™ T-Dip Amphetamine (AMP500) Urine Test Panel Rx SAFElife™ T-Dip Morphine (MOP) Urine Test Panel Rx ONCORE DETOX Single Drug Dip Card (AMP) Single Drug Screen Test ONCORE DETOX Multi-Drug Dip Card Easy@Home® Multi-Drug Screen Test, EDOAP-264 SAFElife™ T-Dip Cocaine (COC150) Urine Test Panel Easy@Home® Single Drug Screen Test SAFElife™ T-Dip Buprenorphine (BUP) Urine Test Panel SAFElife™ T-Dip Cocaine (COC) Urine Test Panel SAFElife™ T-Dip Methamphetamine (MET500/mAMP500) Urine Test Panel SAFElife™ T-Dip Propoxyphene (PPX) Urine Test Panel Rx Easy@Home Multi-Drug Screen Test, EDOAP-4104 ONCORE DETOX Single Drug Dip Card (MET/mAMP) SMC Direct Inc. RefuAH One Step HCG Urine Test (strip) CLARITY MIDSTREAM PREGNANCY TEST SMC Direct Inc. RefuAH One Step HCG Urine Test (cassette) One Step HCG Urine Test PREGNANCY TEST MEDLINE hCG Pregnancy Test Cassette (Urine) One Step HCG Urine Pregnancy Test dealmed HCG Pregnancy Test Cassette Pregnancy Test Strip Easy At Home Medical LLC Easy@Home Early Pregnancy Test (strip) INDICAID™ HCG PREGNANCY TEST STRIP Medline hCG Pregnancy Test Strip (Urine) Wondfo® Pregnancy Test Strip Wondfo® Fertility Combination Tests (Wondfo® Pregnancy Test Strip) Dealmed HCG Pregnancy Test Strip pregmate® Pregnancy Tests Clarity® MIDSTREAM PREGNANCY TEST HORMONElife™ Pregnancy Home Test Midstream HORMONElife™ Pregnancy Test Cassette Rx PREGABLE OVULATION & PREGNANCY TEST KIT (PREGABLE PREGNANCY TEST) UA One Step HCG Urine Test HORMONElife™ Fertility Combination Tests (HORMONElife™ Pregnancy Test Strip) HORMONElife™ Pregnancy Test Strip PRIME SCREEN® Single Panel Urine Test Cotinine (COT) SAFElife™ T-Dip Cotinine (COT) Urine Test Panel SAFElife™ T-Swab Cotinine (COT) Oral Fluid Test WELLlife™ COVD-19 Antigen Test Hough™ COVID-19 Antigen Home Test WELLlife™ COVID-19 Antigen Home Test 2San™ COVID-19 Rapid Self-Test Ovarian Reserve Screening Test HORMONElife™ Ultra Accurate FSH Test Strip COLONOX™ FIT Aydmed Immunochemical Fecal Occult Blood (iFOB) Test EZCHECK® At-home iFOB Test Immunochemical Fecal Occult Blood Test(FIT) INDICAID™ iFOB IMMUNOCHEMICAL FECAL OCCULT BLOOD RAPID TEST RX Preview iFOB Immunochemical Fecal Occult Blood Test (FIT) WELLlife™ iFOB Immunochemical Fecal Occult Blood Test 2San™ Colorectal Health Test (immunochemical fecal occult blood test) INDICAID™ iFOB IMMUNOCHEMICAL FECAL OCCULT BLOOD RAPID TEST COLONOX FIT Immunochemical Fecal Occult Blood Test Test Yourself @ Home™ Immunochemical Fecal Occult Blood Test Toptolife™ iFOB Immunochemical Fecal Occult Blood Test HORMONElife™ Fertility Combination Tests (HORMONElife™ Ovulation Test Strip) Ovulation Tests Easy@Home Ovulation Test Kit (Strip) Wondfo® Ultra Accurate Ovulation Test Strip One Step Ovulation Test Modern Fertility Ovulation Predictor Test Easy@Home Ovulation Test (Midstream) Wondfo® Fertility Combination Tests (Wondfo® Ovulation Test Strip) Ovulation Test Strip pregmate® OVULATION TESTS Modern Fertility Ovulation Test INDICAID™ OVULATION TEST STRIP Wondfo® Ovulation Test Strip Premom Ovulation Test, PMS2-S Ovulation Test (Quantitative Ovulation Predictor) HORMONElife™ Ultra Accurate Ovulation Test Strip Mintegrity® Ovulation Test OVULATION TEST Ovulation Test PREGABLE OVULATION & PREGNANCY TEST KIT (PREGABLE OVULATION TEST) HORMONElife™ Ovulation Test Strip RST Home Drug Test Kit Cup (Urine) RST Home Drug Test Kit Panel (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 UA Fentanyl Urine Test (Cassette) SAFElife™ Fentanyl Urine Home Test (Dip Card) SAFElife™ Fentanyl Urine Test (Cassette) SAFElife™ Fentanyl Urine Home Test (Cassette) UA Fentanyl Urine Test (Dip Card) SAFElife™ Fentanyl Urine Test (Dip Card) Toptolife™ hCG Urine/Serum Combo Pregnancy Test One Step HCG Urine/Serum Test Independent Medical Co-op Inc., IMCO HCG Combo Cassettes Areta Multi-Drug Test Cup Micro Distributing II, Ltd, STAT Cup One Step Drug Test Prime Screen® Multi-Drug Urine Test Cup Easy@Home Multi-Drug Test Cup,ECDOA-1144A3 Clarity Multi-Drug Urine Test Cup (Urine) Easy@Home Drug Test Cup, ECDOA-1144A3 Areta Multi-Drug Test Cup, ACDOA-6125B SAFElife™ F-Cup Multi-Drug Urine Test Cup SAFElife™ T-Cup Multi-Drug Urine Test Cup Areta Multi-Drug Test Cup, ACDOA-754 Easy@Home Drug Test Cup, ECDOA-254 easy@Home® Drug Test Cup iSCREEN™ URINE TEST DRUG SCREEN SQUARE CUP 2SAN Home Drug Test Kit Medline Drug Test Cup Multi-Drug Test Cup IDT Multi Drug Urine Test Compact Cup iSCREEN™ URINE TEST DX DRUG SCREEN COMPACT ROUND CUP PRIME SCREEN® Multi-Drug Urine Test Cup iSCREEN™ URINE TEST DX DRUG SCREEN SQUARE CUP iSCREEN™ Urine Test Dx Drug Screen Round Cup SAFElife™ C-Cup Multi-Drug Urine Test Cup BluRapids® MULTI-DRUG TEST CUP iSCREEN™ URINE TEST DX DRUG SCREEN ROUND CUP iSCREEN™ Urine Test Drug Screen Square Cup easy@Home Drug Test Cup, ECDOA3-6125B Guangzhou Wondfo Biotech Co., Wondfo VacuLid Multi-Drug Urine Test Cup Areta Multi-Drug Test Cup, ACDOA-264 INDICAID™ Multi-Drug Urine Test Cup T-Cup Multi-Drug Urine Test Cup Areta Multi-Drug Test Cup, ACDOA-1144 Drug Test Cup QTEST™ Multi-Drug Urine Test Compact Cup Mintegrity® Multi-Drug Urine Test Cup T-Cup® Compact Multi-Drug Urine Test Cup Easy@Home Drug Test Cup, ECDOA-6125B IDT Multi Drug Urine Test Cup Easy@Home Drug Test Cup, ECDOA-7124 SAFElife™ S-Cup Multi-Drug Urine Test Cup UA Multi-Drug Urine Test Cup T-Cup® Multi-Drug Urine Test Cup CheckNow Multi - Drug Urine Test Cup PRIME SCREEN® Marijuana (THC) Urine Test Strip SAFElife™ Cannabinoids (THC) Urine Test PRIME SCREEN® Cannabinoids (THC) Urine Test Strip SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx iSCREEN™ Urine Test Dx Drug Screen Square Cup SAFElife™ F-Cup Multi-Drug Urine Test Cup Dx SAFElife™ C-Cup Multi-Drug Urine Test Cup Dx SAFElife™ S-Cup Multi-Drug Urine Test Cup Dx Easy@Home Multi-Drug Urine Test Cup Easy@Home Multi-Drug Urine Test Panel Multi-Drug Urine Test Cup, Multi-Drug Urine Test Panel WELLlife™ COVID-19 Antigen Test Rx Control Kit QuickVue Influenza+SARS Test Control Kit WELLlife™ COVID-19 / Influenza A&B Antigen Test Control Kit WELLlife™ Influenza A&B Test Control Kit HORMONElife™ PdG Urine Test Strip Wondfo® PdG Urine Test Easy Healthcare Corporation Areta Drug Test Cup Micro Distributing II Ltd. FASTEST LABS One Step Drug Test Cup Micro Distributing II Ltd. STATCUPII One Step Drug Test Cup easy@Home® Multi-Drug Screen Test TopazFIT Collection Kits SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel Vacu Lid SAFElife™ T-Cup Drug Adulteration Urine Test Cup Toptolife™ Strep A Test Wondfo Biotech Co. Ltd Preview Strep A Test Kit HORMONElife™ Early Result Pregnancy Test Midstream Early Results Pregnancy Tests Bird&Be Early Results Pregnancy Test Get Stix Inc. Early Pregnancy Test Pregnancy Test INDICAID™ HCG EARLY RESULT PREGNANCY TEST STRIP Wondfo® HCG Early Result Pregnancy Test (Midstream) BABYlife™ Early Result Pregnancy Test Wondfo® Extra Sensitive Pregnancy Test Strip Wondfo® Early Result Pregnancy Test Wondfo® Early Result Pregnancy Test Strip Modern Fertility Pregnancy Test Modern Fertility Early Pregnancy Test HORMONElife™ Early Result Pregnancy Test Strip Rx HORMONElife™ Early Result Pregnancy Test Strip Mintegrity® HCG Early Result Pregnancy Test EARLY PREGNANCY TESTS

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198