BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Visby Medical Sexual Health Click Test

    Reg #: 3016608638 · FEI: 3016608638 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    VISBY MEDICAL, INC.
    Registration Number
    3016608638
    FEI Number
    3016608638
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3010 North First Street
    City
    San Jose
    State
    CA
    ZIP
    95134
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200748

    Owner / Operator

    Firm Name
    Visby Medical, Inc.
    Operator Number
    10080245
    Address
    3010 North First Street
    City
    San Jose
    State
    CA
    Postal Code
    95134
    Country
    US
    Correspondent
    Mike Zatzke

    Products

    Device Name Product Code
    Dna-Reagents, Neisseria LSL
    Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections QEP
    Dna Probe, Nucleic Acid Amplification, Chlamydia MKZ
    Trichomonas Vaginalis Nucleic Acid Amplification Test System OUY

    Proprietary Names

    Visby Medical Sexual Health Click Test

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device