BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Herpes Simplex Virus Type 2 / HSV-2 IgG IFA 96 Test

    DI: G522902600 · Model: 902600 · Hemagen Diagnostics, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Herpes Simplex Virus Type 2 / HSV-2 IgG IFA 96 Test
    Primary DI
    G522902600
    Version / Model
    902600
    Company Name
    Hemagen Diagnostics, Inc.
    Labeler DUNS
    147827216
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-05
    Public Version
    1
    Public Version Date
    2023-10-13
    Public Version Status
    New
    Public Device Record Key
    6b0c3aca-ec78-42a3-bcc0-74ceac533595

    Device Description

    For the detection and titration of HSV-2 IgG antibodies in human sera

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2

    GMDN Terms

    Code Name
    49544 Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

    Identifiers

    Type ID
    Primary G522902600

    Customer Contacts

    Phone
    443 367 5500
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K791058 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius