BEUDAMED
    FDA Registration Active 🇨🇳 China

    Hangzhou AllTest Biotech Co.,Ltd

    Reg #: 3043127647 · FEI: 3043127647 · Expires 2026
    View on FDA
    Products
    48
    Proprietary Names
    277
    Establishment Types
    2
    Classifications
    48

    Registration Details

    Registration Name
    Hangzhou AllTest Biotech Co.,Ltd
    Registration Number
    3043127647
    FEI Number
    3043127647
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.616 Dongwei Road, Qiantang District
    City
    Hangzhou Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K241428

    Owner / Operator

    Firm Name
    Hangzhou AllTest Biotech Co.,Ltd
    Operator Number
    10050156
    Address
    #383, Qiaoxin Road, Xiasha Street, Qiantang District
    City
    Hangzhou
    State
    Zhejiang
    Postal Code
    310018
    Country
    CN
    Correspondent
    Rosa Wu

    US Agent

    Business Name
    ACESO LABORATORIES INC.
    Contact Name
    Joseph Fan
    Address
    14020 Central Ave, Suite 520
    City
    Chino
    State
    CA
    ZIP
    91710
    Country
    US
    Email
    [email protected]
    Phone
    909 5415085

    Products

    Device Name Product Code
    Test, Benzodiazepine, Over The Counter NFV
    Test, Barbiturate, Over The Counter PTH
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Methadone, Over The Counter PTG
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Test, Amphetamine, Over The Counter NFT
    Test, Methamphetamine, Over The Counter NGG
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Cannabinoid, Over The Counter NFW
    Test, Opiates, Over The Counter NGL
    Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt PVA
    Test, Morphine, Over The Counter NGI
    Test, Propoxyphene, Over The Counter QBF
    Enzyme Immunoassay, Opiates DJG
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Test, Amphetamine, Employment And Insurance Testing, Exempt PUX
    Test, Benzodiazepine, Employment And Insurance Testing, Exempt PUZ
    Test, Opiates, Employment And Insurance Testing, Exempt PVH
    Culture Media, Non-Propagating Transport JSM
    Test, Methadone, Employment And Insurance Testing, Exempt PVE
    Test, Methamphetamine, Employment And Insurance Testing, Exempt PVD
    Test, Urine Leukocyte LJX
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Visual, Pregnancy Hcg, Prescription Use JHI
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Test, Cannabinoid, Employment And Insurance Testing, Exempt PVJ
    Enzyme Immunoassay, Methadone DJR
    Enzyme Immunoassay, Barbiturate DIS
    Enzyme Immunoassay, Benzodiazepine JXM
    Test, Barbiturate, Employment And Insurance Testing, Exempt PUY
    Paper, Obstetric Ph LNW
    Test, Methaqualone, Employment And Insurance Testing, Exempt PVF
    Test, Propoxyphene, Employment And Insurance Testing, Exempt PVI
    Devices, Breath Trapping, Alcohol DJZ
    Test System, Nicotine, Cotinine, Metabolites MRS
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Test, Morphine, Employment And Insurance Testing, Exempt PVG
    Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Enzyme Immunoassay, Phencyclidine LCM
    Thin Layer Chromatography, Morphine DNK
    Enzyme Immunoassay, Amphetamine DKZ
    Thin Layer Chromatography, Methamphetamine DJC
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Gas Chromatography, Methamphetamine LAF
    Antigens, All Groups, Streptococcus Spp. GTY

    Proprietary Names

    Citest Multi-Drug Urine Cup Rapid Response Drug Screen Cup Atida Multiplex Drug of Abuse Urine Cup Test AllTest Multi-Drug Rapid Urine Test Cup CLIAwaived,Inc. Rapid Test Cup “RTC” + Fentanyl Premier Bio-Cup X ACRO Multi-Drug Rapid Test Cup AllTest Multi-Drug Urine Test Cup DrugTect Multi-Drug Rapid Urine Test Cup Discover Plus Multi-Drug Rapid Urine Test Cup Citest Multi-Drug Urine Test Cup ACRO Multi-Drug Rapid Urine Test Cup Atida Multiplex Drug of Abuse Rapid Urine Cup Test Cocaine(COC) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Identify Diagnostics Multi-Drug Test Cup AllTest Multi-Drug Test Cup Citest Multi-Drug Urine Rapid Test Cup Identify Diagnostics Multi-Drug Rapid Test Cup SafeCup lll Multi-Drug Test Cup Labb Multi Drug Test Cup Identify Health Multi-Drug Rapid Test Cup QuickScreen At Home 18 Panel Drug Test with Fentanyl DrugTect Multi-Drug Rapid Test Cup DrugTect Multi-Drug Test Cup AllTest Multi-Drug Rapid Test Cup CLIAwaived, Inc. Rapid Test Cup Citest Multi-Drug Test Cup PRECISION PLUS Multi-Drug Test Cup Atida Multiplex Drug of Abuse Test Cup CERTUM Multi-Drug Test Cup CLIAwaived, Inc. Multi-Drug Rapid Test Cup Atida Multiplex Drug of Abuse Cup Test ACRO Rapid drug Screen Cup ACRO Rapid drug Screen Cup for Home use Identify Health Multi-Drug Test Cup CHOSEN Multi-Drug Test Cup Exploro Urine Drug Test Cup Rapid Response Multi-Drug Screen Cup Discover Multi-Drug Test Cup Labb Multi Drug Rapid Test Cup CHOSEN Multi-Drug Rapid Test Cup Berkeley health Multi-Drug Rapid Test CHOSEN Multi-Drug Urine Test Cup ACRO Multi-Drug Screen Cup Identify Health Multi-Drug Rapid Urine Test Cup Identify Diagnostics Multi-Drug Urine Test Cup CHOSEN Multi-Drug Rapid Urine Test Cup ACRO Multi-Drug Screen Cup for Home use Identify Health Multi-Drug Urine Test Cup CLIAwaived,Inc. Complete Drug Test Cup “CDTC” Labb Multi Drug Urine Test Cup Labb Multi Drug Rapid Urine Test Cup DrugTect Multi-Drug Urine Test Cup ONESCREEN PLUS Multi-Panel Drug Test Cup Identify Diagnostics Multi-Drug Rapid Urine Test Cup AllTest Fentanyl Rapid Test (Urine) Discover Fentanyl Rapid Test Cassette Rx Fentanyl Test (Urine) Rapid Response Fentanyl Test Cassette (Urine) Atida Fentanyl Drug of Abuse Test Rx CHOSEN Fentanyl Urine Rapid Test Cassette Rx Identify Health Digital Early Pregnancy Test Shinetell Plus Digital Early Pregnancy Test Citest Digital Early Pregnancy Home Test QuickScreen At Home Digital Early Pregnancy Test Atida Digital Early Pregnancy Test 2San Digital Early Pregnancy Test Optilyte Plus Digital Early Pregnancy Rapid Test Discover Fentanyl Rapid Test Cassette Atida Fentanyl Drug of Abuse Test Identify Health Fentanyl Urine Test Cassette McKesson Consult Fentanyl Urine Test Cassette Atida Fentanyl Test One Step Fentanyl Urine Test Cassette CHOSEN Fentanyl Rapid Urine Test Cassette Rapid Response Fentanyl Test Cassette CHOSEN Fentanyl Urine Rapid Test Cassette Mobilab Fentanyl Urine Test Cassette GenaCheck Fentanyl Urine Test Cassette Citest Fentanyl Home Test ACRO Fentanyl Urine Test Cassette DrugTect Fentanyl Urine Cassette RapiSure Fentanyl Urine Test Cassette ACRO Fentanyl Urine Test AllTest FentanyI Urine Test Cassette (Home Test) Rapid Response At-Home Fentanyl Test Cassette GenaCheck Fentanyl Urine Home-Use Test Cassette CLIAwaived, Inc. Rapid Drug Test Device“RDTD”for Fentanyl in Urine AimScreen Fentanyl Test 2SAN Fentanyl Urine Test Cassette RapiSure FYL Fentanyl Urine Test Cassette Identify Diagnostics Fentanyl Urine Cassette Citest Fentanyl Rapid Test Optilyte Digital Pregnancy Rapid Test Identify Health Digital Pregnancy Test Citest Digital Pregnancy Home Test CHOSEN Digital hCG Pregnancy Urine Rapid Test Midstream Atida Digital Pregnancy Test Rapid Response Digital Pregnancy Test Discover Digital Pregnancy Test Shinetell™ Digital Pregnancy Test CHOSEN hCG Early Pregnancy Urine Rapid Test Midstream ACRO Early Pregnancy Rapid Test ACESO Early Pregnancy Test Atida Early Pregnancy Test 2San Early Result Pregnancy Test Berkeley health hCG Early Pregnancy Rapid Test Citest Early Pregnancy Home Test ALLTEST hCG Early Pregnancy Rapid Test getTested Early Pregnancy Test One Step hCG Early Rapid Pregnancy Test Midstream Identify Health hCG Early Pregnancy Rapid Test THYROCHEK Thyroid Test Rapid TSH Cassette (Whole Blood) CLIAwaived Inc. Thyroid Test Rapid TSH Cassette (Whole Blood) AMPHETAMINE(AMP) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Benzodiazepines(BZO) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Opiates(OPI) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Atida Viral Transport Medium Citest Viral Transport Medium ACRO Viral Transport Medium AllTest Viral Transport Medium Methadone(MTD) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Methamphetamine(MET) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Drink Check Test AllTest Urinary Tract Infection Test Atida Urinary Tract Infection Test Urinary Tract Infection Test Identify Health Urinary Tract Infection Test Rapid Response Urinary Tract infection Screen Strips Berkeley health Urinary Tract Infections Rapid Test 2San UTI Test Mobilab Urinary Tract Infection Test Vivoo At-Home UTI Test Strips Citest Urinary Tract Infection Test ACRO Urinary Tract Infection Rapid Test QuickScreen At Home Urinary Tract Infection Test Alltest Pregnancy Rapid Combo Test Cassette Citest hCG Pregnancy Combo Rapid Test Atida hCG Pregnancy Rapid Combo Test ACRO hCG Pregnancy Combo Test CLARITY hCG Combo Cassette Medline hCG Combo Pregnancy Test Cassette CHOSEN hCG Pregnancy Combo Rapid Test Cassette Rx Identify Health Pregnancy Rapid Combo Test Cassette Ovulation (LH) Rapid Test Cassette Ovulation (LH) Rapid Test Dipstick Digital LH Ovulation Test Strip Ovulation (LH) Rapid Test Midstream BERKELEY HEALTH Ovulation LH Test QuickScreen At Home Digital Ovulation Test Marijuana(THC) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT QuickScreen Multi Drug Screening Test With "Timer" Barbiturate(BAR) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT BERKELEY HEALTH Vaginal pH Test Methaqualone(MQL) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Propoxyphene(PPX) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT WorkCHEK Breath Alcohol Test, For employment and insurance use Cotinine (COT) Rapid Test Panel Powder Cotinine (COT) Rapid Test Cassette Oral Fluid iSCREEN™ ORAL FLUID DRUG TEST(product code: ABTDCTCUBO0102) Cotinine (COT) Rapid Test Certum Adulteration Dipstick Adulteration Dipstick Morphine(MOP) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT FSH Rapid Test Cassette FSH Rapid Test Midstream FSH Rapid Test Dipstick QuickScreen At Home FSH/Menopause Rapid Test (Urine) One Step FSH Urine midstream Test BERKELEY HEALTH Menopause FSH Test One Step FSH Urine test strip VeriCheck Drug Test Cup (Urine) One Step Ecstasy (MDMA) Urine Test Strip ACRO Single Drug Test Strip One Step Cocaine (COC) Urine Test Strip Clarity Diagnostics Multi-Drug Home Rapid Test Cup (Urine) Citest Single Drug Rapid Test Strip AllTest Single and Multi-Drug Rapid Test Panel With Adulteration AllTest Single and Multi-Drug Home Rapid Test Cup AllTest Single Drug Home Rapid Test Dipstick AllTest Single and Multi-Drug Home Rapid Test Panel AllTest Single Drug Rapid Test Dipstick AllTest Single and Multi-Drug Rapid Test Cup AllTest Single and Multi-Drug Rapid Test Panel AllTest Single and Multi-Drug Rapid Test Cup With Adulteration One Step THC Rapid Urine Test Strips CHOSEN Single Drug Urine Rapid Test Dipstick Multi-Drug Rapid Test Cup With or without Adulteration (Urine) Rapid Response Drug Screening Test Strip- OTC (Urine) Citest Single Drug Test Strip Citest Multiplex DOA Home Test Panel (Urine) ACRO Single Drug Urine Test Strip Citest Multiplex DOA Home Test Cup (Urine) Rapid Response Drug Screening Panel w/wo Adulteration (Urine) One Step Methamphetamine (MET) Urine Test Strip Rapid Response Drug Screening Cup w/wo Adulteration (Urine) Citest Multiplex DOA Test Panel (Urine) VeriCheck Drug Test Dip (Urine) Test Yourself At Home Home Rapid Test Cup Rapid Response Drug Screening Panel- OTC (Urine) Atida Single Drug Drug of Abuse Strip Test Rx One Step Amphetamine (AMP) Urine Test Strip CHOSEN Single Drug Urine Rapid Test Dipstick Rx One Step Benzodiazepine (BZO) Urine Test Strip Atida Single Drug Drug of Abuse Strip Test One Step Morphine (MOP) Urine Test Strip Rapid Response Drug Screening Cup- OTC (Urine) L-Cup Home Rapid Test (Urine) L-Cup Rapid Test w/Adulteration (Urine) Citest Multiplex DOA Test Cup (Urine) Multi-Drug Rapid Test Panel With or without Adulteration (Urine) Rapid Response Drug Screening Strip w/wo Adulteration (Urine) L-Cup Drug Test (Urine) Discover Multi-Drug Rapid Test Cup (Urine) Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine) Atida Multiplex Drug of Abuse Dip Card Test Citest Multi Drug Test Panel AimScreen Multi-Drug Test Panel CHOSEN Multi-Drug Urine Rapid Test Panel Rx ACRO Multi-Drug Urine Test Panel AllTest Multi-Drug Rapid Test Panel AllTest Multi-Drug Rapid Test Cup Rx One Step 7 Drug Multi-Panel Urine Test Citest Multi Drug Rapid Test Panel BEB Multi-Drug Rapid Test Cup Exploro Highly Sensitive 5-PANEL URINE DRUG TEST Discover Multi-Drug Rapid Test Panel SpecCheck Multi-Drug Rapid Test Cup ACRO Multi-Drug Urine Test Cup PRECISION DX Multi-Panel Drug Test Card CHOSEN Multi-Drug Urine Rapid Test Panel Citest Multi Drug Test Cup PRECISION DX Multi-Drug Rapid Urine Test Cup CHOSEN Multi-Drug Urine Rapid Test Cup Rx Mobilab Multi-Drug Rapid Test CUP AllTest Multi-Drug Rapid Test Panel Rx Mobilab Multi-Drug Rapid Test Panel Atida Multiplex Drug of Abuse Cup Test Rx Identify Health Multi-Drug Rapid Test Dip CHOSEN Multi-Drug Urine Rapid Test Cup Citest Multi Drug Rapid Test Cup ACRO Multi-Drug Test Cup ACRO Multi-Drug Test Panel Atida Multiplex Drug of Abuse Dip Card Test Rx SpecCheck Multi-Drug Rapid Test Panel Identify Diagnostics Multi-Drug Rapid Test Panel AllTest Strep A Rapid Test QUICKSTICK ONE STEP PREGNANCY TEST Define-Test de Embarazo HCG HCG OTC Rapid Urine Test Midstream HCG Pregnancy Rapid Test Midstream One Step Self-Test Pregnancy Test Midstream ALLTEST hCG Pregnancy Rapid Test Citest Pregnancy Home Test Test Yourself @ Home (TY@H) One-Step Pregnancy Test Atida Pregnancy Test Identify Diagnostics Multi-Drug Rapid Urine Test Dip Identify Diagnostics Multi-Drug Urine Test Dip Identify Health Multi-Drug Rapid Urine Test Dip AllTest Multi-Drug Urine Test Panel Citest Multi-Drug Urine Test Panel Citest Multi-Drug Urine Panel Atida Multiplex Drug of Abuse Rapid Urine Dip Card Test CHOSEN Multi-Drug Urine Test Panel Premier Bio-Dip X Atida Multiplex Drug of Abuse Urine Dip Card Test CHOSEN Multi-Drug Rapid Urine Test Panel AllTest Multi-Drug Rapid Urine Test Panel DrugTect Multi-Drug Urine Test Panel Rapid Response Drug Screen Panel Identify Health Multi-Drug Urine Test Dip ACRO Multi-Drug Rapid Urine Test Panel DrugTect Multi-Drug Rapid Urine Test Panel ONESCREEN PLUS Multi-Drug Rapid Urine Test Panel ACRO Multi-Drug Rapid Test Panel PRECISION PLUS Multi-Panel Rapid Urine Test Card Discover Multi-Panel Rapid Urine Test Card

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)