BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ENA-6Pro ELISA

    DI: B24235E6PHUE010 · Model: 35-E6PHU-E01 · AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ENA-6Pro ELISA
    Primary DI
    B24235E6PHUE010
    Version / Model
    35-E6PHU-E01
    Catalog Number
    35-E6PHU-E01
    Company Name
    AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
    Labeler DUNS
    784143778
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-08-28
    Public Version
    5
    Public Version Date
    2022-09-20
    Public Version Status
    Update
    Public Device Record Key
    11a34958-36ea-4a82-a940-f6c349d5d41d
    Distribution End Date
    2019-08-01

    Device Description

    The ENA-6Pro ELISA is a solid phase enzyme immunoassay for the separate semiquantitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. The wells are coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is an aid in the differential diagnosis of systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings.

    Device Characteristics

    Single Use
    Yes
    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
    LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

    GMDN Terms

    Code Name
    54823 Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary B24235E6PHUE010

    Customer Contacts

    Phone
    800.592.5726
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K032469 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius