BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Mutlicode®-RTx HSV 1&2 Kit

    DI: 00840487101032 · Model: 3711 · LUMINEX CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Mutlicode®-RTx HSV 1&2 Kit
    Primary DI
    00840487101032
    Version / Model
    3711
    Catalog Number
    3711
    Company Name
    LUMINEX CORPORATION
    Labeler DUNS
    079686463
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-09
    Public Version
    3
    Public Version Date
    2021-01-22
    Public Version Status
    Update
    Public Device Record Key
    ac88ffb3-3cf1-453b-b549-3f3a4eb8fe0c
    Distribution End Date
    2021-01-21

    Device Description

    The MultiCode®-RTx Herpes Simplex Virus 1 & 2 Kit is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV 1 & 2) DNA in vaginal lesions. It is indicated for use in the detection and typing of HSV-1 or HSV-2 in vaginal lesion swab specimens from symptomatic female patients as an aid in the diagnosis of genital herpes infection.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    OQO Herpes simplex virus nucleic acid amplification assay

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 00840487101032

    Customer Contacts

    Phone
    +1(866)327-3290
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -30 – -15 Degrees Celsius