BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    CMV Primer ASR

    DI: 04053228040972 · Model: V1 · QIAGEN GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    CMV Primer ASR
    Primary DI
    04053228040972
    Version / Model
    V1
    Catalog Number
    1124260
    Company Name
    QIAGEN GmbH
    Labeler DUNS
    317103745
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-06-02
    Public Version
    2
    Public Version Date
    2025-08-19
    Public Version Status
    Update
    Public Device Record Key
    932c2ef4-1c10-4b88-8b74-75b7bb99000f
    Distribution End Date
    2025-08-18

    Device Description

    The CMV Primer ASR contains a specific nucleic acid sequence for the amplification of cytomegalovirus (CMV). The CMV Primer ASR is designed to detect a 105 bp region of the MIE gene in the CMV genome. The DNA is synthetically derived. Analyte Specific Reagent. Analytical and performance characteristics are not established.

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MVU Reagents, Specific, Analyte

    GMDN Terms

    Code Name
    30798 Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 04053228040972

    Customer Contacts

    Phone
    1-800-426-8157
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -30 – -15 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    Store in constant temperature freezer.