BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Aptiva® CTD Essential Reagent

    DI: 08430793040051 · Model: 723100 · INOVA DIAGNOSTICS, INC.
    View on AccessGUDID
    Product Codes
    7
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Aptiva® CTD Essential Reagent
    Primary DI
    08430793040051
    Version / Model
    723100
    Company Name
    INOVA DIAGNOSTICS, INC.
    Labeler DUNS
    188354831
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-12-14
    Public Version
    1
    Public Version Date
    2023-12-22
    Public Version Status
    New
    Public Device Record Key
    6a8bdde4-933e-400c-934a-26c9ab4eeca5

    Device Description

    1. Aptiva CTD Essential Reagent Cartridge: a. CTD Essential Beads -Synthetic dsDNA antigen -Native RNP antigen -Sm and Ribosomal-P peptides -Recombinant Ro52, Ro60, SSB, Scl-70, Jo-1, Centromere B and DFS70 antigen -Anti-human IgG antigen (goat) -Bovine protein stabilizer b. Assay buffer -Bovine protein stabilizer -Sodium azide c. PE Tracer IgG -Goat anti-human IgG -Bovine protein stabilizer -Sodium azide d. Rehydration buffer Bovine protein stabilizer Sodium azide

    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
    LLL Extractable Antinuclear Antibody, Antigen And Control
    OBE Anti-Ss-A 52 Autoantibodies
    LKP Anti-Sm Antibody, Antigen And Control
    LKO Anti-Rnp Antibody, Antigen And Control
    LIM Test, Screening, For D Positive Fetal Rbc'S
    MQA Anti-Ribosomal P Antibodies
    LSW Anti-Dna Antibody, Antigen And Control

    GMDN Terms

    Code Name
    54810 Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex

    Identifiers

    Type ID
    Primary 08430793040051

    Customer Contacts

    Phone
    1-800-678-0710
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K213403 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius