BEUDAMED
    FDA Registration Active 🇨🇳 China

    ACRO Early Pregnancy Rapid Test

    Reg #: 3012073813 · FEI: 3012073813 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Hangzhou AllTest Biotech Co.,Ltd
    Registration Number
    3012073813
    FEI Number
    3012073813
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 550, Yinhai Street, Hangzhou Economic & Technological Development Area
    City
    Hangzhou Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K234152

    Owner / Operator

    Firm Name
    Hangzhou AllTest Biotech Co.,Ltd
    Operator Number
    10050156
    Address
    No. 550, Yinhai Street, Hangzhou Economic & Technological Development Area
    City
    Hangzhou
    State
    Zhejiang
    Postal Code
    310018
    Country
    CN
    Correspondent
    Yanli 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
    310 8060719

    Products

    Device Name Product Code
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX

    Proprietary Names

    ACRO Early Pregnancy Rapid Test One Step hCG Early Rapid Pregnancy Test Midstream ALLTEST hCG Early Pregnancy Rapid Test Identify Health hCG Early Pregnancy Rapid Test Citest Early Pregnancy Home Test ACESO Early Pregnancy Test Early Detection Pregnancy hCG Test CHOSEN hCG Early Pregnancy Urine Rapid Test Midstream getTested Early Pregnancy Test

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)