BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ADVIN BIOTECH, INC.

    Reg #: 3010934853 · FEI: 3010934853 · Expires 2026
    View on FDA
    Products
    39
    Proprietary Names
    109
    Establishment Types
    5
    Classifications
    39

    Registration Details

    Registration Name
    ADVIN BIOTECH, INC.
    Registration Number
    3010934853
    FEI Number
    3010934853
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10140 Mesa Rim Rd., Unit 1
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K252867

    Owner / Operator

    Firm Name
    Advin Biotech Inc
    Operator Number
    10046939
    Address
    10140 Mesa Rim Rd., Unit 1
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US
    Correspondent
    Yedda Huang

    Products

    Device Name Product Code
    Enzyme Immunoassay, Opiates DJG
    Enzyme Immunoassay, Amphetamine DKZ
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Thin Layer Chromatography, Methamphetamine DJC
    Enzyme Immunoassay, Phencyclidine LCM
    Enzyme Immunoassay, Cannabinoids LDJ
    Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt PVA
    Enzyme Immunoassay, Methadone DJR
    Multi-Analyte Controls Unassayed OHQ
    Coronavirus Antigen Detection Test System. QKP
    Test, Benzodiazepine, Employment And Insurance Testing, Exempt PUZ
    Test, Methamphetamine, Over The Counter NGG
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Test, Methadone, Over The Counter PTG
    Test, Opiates, Over The Counter NGL
    Test, Cannabinoid, Over The Counter NFW
    Test, Benzodiazepine, Over The Counter NFV
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Propoxyphene, Over The Counter QBF
    Test, Barbiturate, Over The Counter PTH
    Test, Amphetamine, Over The Counter NFT
    Enzyme Immunoassay, Barbiturate DIS
    Enzyme Immunoassay, Propoxyphene JXN
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Enzyme Immunoassay, Benzodiazepine JXM
    Test, Cannabinoid, Employment And Insurance Testing, Exempt PVJ
    Test, Methamphetamine, Employment And Insurance Testing, Exempt PVD
    Test, Propoxyphene, Employment And Insurance Testing, Exempt PVI
    Enzyme Immunoassay, Nicotine And Nicotine Metabolites MKU
    Test, Opiates, Employment And Insurance Testing, Exempt PVH
    Test, Amphetamine, Employment And Insurance Testing, Exempt PUX
    Reagent, Coronavirus Serological QKO
    Test, Morphine, Employment And Insurance Testing, Exempt PVG
    Test System, Nicotine, Cotinine, Metabolites MRS
    Test, Codeine, Employment And Insurance Testing, Exempt PVB
    Test, Barbiturate, Employment And Insurance Testing, Exempt PUY
    Test, Methadone, Employment And Insurance Testing, Exempt PVE
    Test, Methaqualone, Employment And Insurance Testing, Exempt PVF

    Proprietary Names

    OralTox Oral Fluid Drug Test KNOW DRUG TEST CUP Advin Multi Drug Screen Test ATTEST DRUG TEST COVID-19 IgG/IgM (-) Control COVID-19 IgG/IgM (+) Control Advin COVID-19 Antigen Test @Home QuikTox Ultra Cup Rapid Drug Test Multi-Drug Screen Test Cup MYM Multi-Drug Urine Test Cup Topaz Multi Screen Test Cup RED TUNICA DOPI™ Multi-Drug Detection System Premier Bio-Cup Rapid Test CheckTox Multi-Drug Test Cup DrugExam Multi Drug Screen Test Cup INSTA-SCREEN-2® Test Cup Identify® Health Drug Screen Test Cup VistaFlow Test Cup Identify Diagnostics Drug Test Identify® Diagnostics USA Drug Test Noble Drug Test Cup QuikTox @Home Ultra Cup CLIAWaived Inc. Instant Drug Test Cup Plus Bicycle Health CLIA Waived Drug Test Cup CLIAWaived Inc. Multi-Drug Screen Test Cup Plus Premier Bio-Cup & Bio-Dip ATTEST Drug Screen Cup & DIP Card Multi-Drug Screen Test KNOW DRUG CUP SmartScreen cup Premier BIO CUP & BIO DIP ATTEST RightSign Delta-9 THC Saliva Tracer Test ATTEST Drug Test KNOW Drug Test Cup SmartScreen Cup Premier Bio Cup & Bio Dip Identify Diagnostics USA Drug Screen Test (MET) Identify Health Drug Screen Test (AMP) Identify Diagnostics USA Drug Screen Test (OPI300) CheckTox Multi-Drug Test Bicycle Health CLIA WAIVED DRUG TEST (MTD) Identify Health Drug Screen Test (TCA) Bicycle Health CLIA WAIVED DRUG TEST (BUP) Identify Diagnostics USA Drug Screen Test (OXY) Versea Easy Lab 6 Drugs Home Testing Kit Premier UTox Cup QuikTox Ultra Cup & Ultra Dip DrugExam Multi Drug Screen Test Identify Health Drug Screen Test (BUP) Identify Diagnostics USA Drug Screen Test (BAR) Bicycle Health CLIA WAIVED DRUG TEST (OPI2000) Rapid Response™ Multi-Drug One Step Cup (Urine) Bicycle Health CLIA WAIVED DRUG TEST (BAR) Identify Health Drug Screen Test (PPX) Identify Diagnostics USA Drug Screen Test (TCA) Advin Multi-Drug Screen Test Cassette/Cup/Dip Card Identify Health Drug Screen Test (OPI300) NexScreen Drug Screen Cup Identify Diagnostics USA Drug Screen Test (MTD) Identify Health Drug Screen Test (BZO) Identify Diagnostics USA Drug Screen Test (MDMA) VistaFlow test yourself @home Instant Drug Test Cup INSTA-SCREEN-2 Cup Bicycle Health CLIA WAIVED DRUG TEST (BZO) Bicycle Health CLIA WAIVED DRUG TEST (PPX) Identify Diagnostics USA Drug Screen Test (AMP) Identify Diagnostics USA Drug Screen Test (COC) Bicycle Health CLIA WAIVED DRUG TEST (THC) RightSign Drug Screen Test Identify Health Drug Screen Test (OXY) Identify Diagnostics USA Drug Screen Test (PPX) Identify Health Drug Screen Test (MET) Identify Health Drug Screen Test (MTD) Identify Diagnostics USA Drug Screen Test (BZO) Bicycle Health CLIA WAIVED DRUG TEST (PCP) Bicycle Health CLIA WAIVED DRUG TEST (OXY) Bicycle Health CLIA WAIVED DRUG TEST (COC) Identify Health Drug Screen Test (THC) Identify Health Drug Screen Test (EDDP) Bicycle Health CLIA WAIVED DRUG TEST (MDMA) Instant Drug Test Cup/Card II (IDTC II) Boulder Care Multi-Drug Test Cup QuikTox Ultra Cup Identify Diagnostics USA Drug Screen Test (OPI2000) Identify Diagnostics USA Drug Screen Test (EDDP) Identify Health Drug Screen Test (COC) Sienna Multi-Drug Test (Cup and Dip Card) Bicycle Health CLIA WAIVED DRUG TEST(OPI300) Identify Diagnostics USA Drug Screen Test (THC) Identify Health Drug Screen Test (PCP) Bicycle Health CLIA WAIVED DRUG TEST (MET) Identify Health Drug Screen Test (OPI2000) Identify Diagnostics USA Drug Screen Test (PCP) Bicycle Health CLIA WAIVED DRUG TEST (EDDP) Bicycle Health CLIA WAIVED DRUG TEST (AMP) Identify Diagnostics USA Drug Screen Test (BUP) Noble Dip Card/Drug Test Cup Precision Plus Multi Panel Urine Drug Test Cup Bicycle Health CLIA WAIVED DRUG TEST (TCA) Identify Health Drug Screen Test (BAR) Utest Drug Test Identify Health Drug Screen Test (MDMA) CoronaCheck COVID-19 IgG/IgM Rapid Test Cassette RightSign COVID-19 IgG/IgM Rapid Test Cassette Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette ALOFT Cotinine SmartScreen MQL

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Repack or Relabel Medical Device Manufacture Device in the United States for Export Only Develop Specifications But Do Not Manufacture At This Facility