BEUDAMED
    FDA Registration Active 🇨🇳 China

    Guangzhou Decheng Biotechnology Co., Ltd.

    Reg #: 3017904598 · FEI: 3017904598 · Expires 2026
    View on FDA
    Products
    35
    Proprietary Names
    114
    Establishment Types
    3
    Classifications
    35

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    Registration Details

    Registration Name
    Guangzhou Decheng Biotechnology Co., Ltd.
    Registration Number
    3017904598
    FEI Number
    3017904598
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road, Science City, Huangpu District
    City
    Guangzhou Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K230038

    Owner / Operator

    Firm Name
    Guangzhou Decheng biotechnology co., Ltd.
    Operator Number
    10079520
    Address
    Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road, Science City, Huangpu District
    City
    Guangzhou
    State
    Guangdong
    Postal Code
    510663
    Country
    CN
    Correspondent
    haisheng Hu

    US Agent

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

    Products

    Device Name Product Code
    Test, Methadone, Employment And Insurance Testing, Exempt PVE
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Test, Methamphetamine, Employment And Insurance Testing, Exempt PVD
    Test, Opiates, Over The Counter NGL
    Test, Benzodiazepine, Employment And Insurance Testing, Exempt PUZ
    Immunoassay, Pregnanediol Glucuronide, Over The Counter QKE
    Test, Barbiturate, Employment And Insurance Testing, Exempt PUY
    Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA
    Enzyme Immunoassay, Benzodiazepine JXM
    Enzyme Immunoassay, Opiates DJG
    Enzyme Immunoassay, Barbiturate DIS
    Test, Propoxyphene, Over The Counter QBF
    Test, Methadone, Over The Counter PTG
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Propoxyphene JXN
    Enzyme Immunoassay, Amphetamine DKZ
    Enzyme Immunoassay, Cannabinoids LDJ
    Test, Amphetamine, Over The Counter NFT
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Thin Layer Chromatography, Methamphetamine DJC
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Test, Methamphetamine, Over The Counter NGG
    Enzyme Immunoassay, Methadone DJR
    Test, Cannabinoid, Over The Counter NFW
    Test, Barbiturate, Over The Counter PTH
    Enzyme Immunoassay, Phencyclidine LCM
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Benzodiazepine, Over The Counter NFV
    Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt PVA
    Test, Cannabinoid, Employment And Insurance Testing, Exempt PVJ
    Test, Opiates, Employment And Insurance Testing, Exempt PVH
    Test System, Nicotine, Cotinine, Metabolites MRS
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Test, Amphetamine, Employment And Insurance Testing, Exempt PUX

    Proprietary Names

    UScreen Oral® Saliva Drug Test Pen Amazewell™ D-Pen™ Oral Fluid Drug Test Amazewell™ Lollipop Oral Fluid Drug Test MGC HEALTH™ D-PEN™ ORAL FLUID DRUG TEST Wondfo Pregnancy Test pregmate® PREGNANCY Test Strips kozekoze Pregnancy Test MissLan® Pregnancy Rapid Test Strip MissLan® Pregnancy Rapid Test (Strip) exchange select™ Analog Pregnancy Rapid Test Walgreens Pregnancy Test Strips MissLan® Pregnancy Rapid Test (Midstream) Pregnancy Test Strip easy@Home® PREGNANCY TEST Amazewell™ Pregnancy Rapid Test Strip MGC HEALTH™ ANALOG PREGNANCY RAPID TEST Amazewell™ Pregnancy Rapid Test Midstream MissLan® Pregnancy Rapid Test Midstream pregmate® Pregnancy Midstream Test Pregnancy Rapid Test Midstream CVS™ PREGNANCY TEST STRIPS Hy-Vee® Analog Pregnancy Rapid Test SURESIGN™ Pregnancy Rapid Test Pregnancy Rapid Test (Strip) CVSHealth® 6 Drugs Oral Test Kit Fentanyl Urine Test easy@Home® EARLY DETECTION PREGNANCY TEST One Step® HCG Early Rapid Pregnancy Strips Amazewell™ Early Detection Pregnancy Test Strip MissLan® Early Detection Pregnancy Test Strip MissLan® Early Detection Pregnancy Test Cassette kozekoze Early Detection Pregnancy Test MissLan® Early Detection Pregnancy Test Midstream Amazewell™ Early Detection Pregnancy Test Midstream INDICAID™ Early Detection Pregnancy Test Strip exchange select™ Early Detection Pregnancy Test 6 Days Sonner SURESIGN™ Early Detection Pregnancy Test MGC HEALTH™ EARLY DETECTION PREGNANCY TEST Early Detection Pregnancy Test One Step® HCG Early Rapid Pregnancy Midstream Test Hy-Vee® 6 Days Sooner/Early Detection Pregnancy Test Early Detection Pregnancy Test Cassette equate™ 6 Days Sooner Pregnancy Test Strip Carethetic® PdG Urine Test easy@Home® PdG Urine Test One Step® Progesterone (PdG) Urine Test Strip PdG Urine Test Strip SURESIGN™ Menopause (FSH) Rapid Test VeriQuick® At Home Menopause Test Strip easy@Home® FSH Urine Test PREGMATE® MENOPAUSE TEST STRIPS MGC HEALTH™ DIGITAL PREGNANCY RAPID TEST MissLan® Digital Pregnancy Rapid Test Amazewell™ Digital Pregnancy Rapid Test SURESIGN™ Digital Pregnancy Rapid Test Digital Pregnancy Rapid Test BEB® Digital Pregnancy Rapid Test BABYlife™ DIGITAL PREGNANCY TEST pregmate Digital Pregnancy Test exchange select™ Digital Pregnancy Rapid Test Hy-Vee® Digital Pregnancy Rapid Test NOBLE Multi-Drug Urine Test Dipcard EZCHECK® Marijuana (THC) Urine Test EZCHECK® Multi-Drug Urine Test Dipcard Amazewell™ Single Drug Urine Test Dipcard Dochek® Multi-Drug Urine Test Dipcard Amazewell™ Multi-Drug Urine Test Dipcard UScreen™ Multi-Drug Urine Test Dipcard Dochek® Multi-Drug Urine Test Dipcard Rx MYM Multi-Drug Urine Test Dipcard IDT Multi-Drug Urine Test Dipcard One Step® 7-PANEL MULTI DRUG URINE TEST MGC HEALTH™ D-PEN™ MINI COC ORAL FLUID TEST CVSHealth® 1 Drug Oral Test Kit Amazewell™ D-Pen™ Mini THC Oral Fluid Test MGC HEALTH™ D-PEN™ MINI THC ORAL FLUID TEST Amazewell™ D-Pen™ Mini COT Oral Fluid Test magentacup™ Multi-Drug Urine Test Cup Dochek® Multi-Drug Urine Test Cup Xpeedy Multi-Drug Urine Test Cup Dochek® Multi-Drug Urine Test Cup Rx IDT Multi-Drug Urine Test Clicker Cup AllSource DRUG DETECTOR UScreen™ RAPID DRUG TEST CUP EZCHECK® Multi-Drug Urine Test Clicker Cup BEB® Multi-Drug Urine Test Cup Amazewell™ Multi-Drug Urine Test Clicker Cup NOBLE Multi-Drug Urine Test Cup premom® Ovulation Test Hy-Vee® Ovulation Kit SURESIGN™ Ovulation Rapid Test Midstream easy@Home® Ovulation Test One Step® LH Ovulation Rapid Test Dipstick (Urine) MissLan® One Step LH Urine Test Strip Amazewell™ Ovulation Rapid Test Midstream Amazewell™ Semi-quantitative Ovulation Rapid Test Strip pregmate® OVULATION Test Strips MGC HEALTH™ OVULATION RAPID TEST PREGMATE® Digital Ovulation Test MissLan® One Step LH Urine Test Midstream MissLan® Digital Ovulation Rapid Test Amazewell™ Ovulation Rapid Test Strip SURESIGN™ Digital Ovulation Rapid Test Hy-Vee® Ovulation Rapid Test pregmate® Ovulation Test SAVVONA Color Scale Ovulation Predictor Test SURESIGN™ Digital Ovulation Rapid Test Holder premom® Semi-quantitative Ovulation Test Amazewell™ Digital Ovulation Test Kit PREGMATE® Digital Ovulation Reader exchange select™ Ovulation Rapid Test CVS™ OVULATION TEST STRIPS kozekoze Ovulation Test SURESIGN™ Digital Ovulation Rapid Test Stick

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device