BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HSV 1&2 ELITe MGB Assay

    DI: 03661540950025 · Model: M800584 · Elitechgroup Mdx LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HSV 1&2 ELITe MGB Assay
    Primary DI
    03661540950025
    Version / Model
    M800584
    Company Name
    Elitechgroup Mdx LLC
    Labeler DUNS
    117458512
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-12-14
    Public Version
    3
    Public Version Date
    2023-06-19
    Public Version Status
    Update
    Public Device Record Key
    afc733fc-e7ed-4932-8055-3a1968be8645

    Device Description

    HSV 1&2 ELITe MGB Assay for the detection of HSV. A collection of reagents and other materials intended to be used for the qualitative detection of nucleic acid from herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen, using a nucleic acid technique (NAT). This is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    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
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    Yes

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

    GMDN Terms

    Code Name
    49539 Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 03661540950025

    Premarket Submissions

    Submission Number Supplement Number
    K180559 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -20 – -15 Degrees Celsius