BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LDH Reagent Set

    DI: 00812137012005 · Model: R1 x 500mL, R2 x 125mL · CLINICAL DIAGNOSTIC SOLUTIONS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    LDH Reagent Set
    Primary DI
    00812137012005
    Version / Model
    R1 x 500mL, R2 x 125mL
    Catalog Number
    501-413
    Company Name
    CLINICAL DIAGNOSTIC SOLUTIONS, INC.
    Labeler DUNS
    048144997
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2016-10-12
    Public Version
    3
    Public Version Date
    2024-04-03
    Public Version Status
    Update
    Public Device Record Key
    04371e3e-0f00-4c0a-9eaa-bd9123c5623a

    Device Description

    For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. Increased levels of LD are associated with myocardial infarction. Levels reach a maximum approximately 48 hours after the onset of pain and persist about ten days. The degree of elevation is of value in assessing the extent of damage and in developing a prognosis. LD elevations are also observed in liver disease, pernicious anemia, in some cases of renal disease, and in some cases of skeletal muscle trauma.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    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
    CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

    GMDN Terms

    Code Name
    53089 Lactate dehydrogenase 5 (LDH-5) isoenzyme IVD, reagent

    Identifiers

    Type ID
    Primary 00812137012005
    Unit of Use 00812137012333

    Customer Contacts

    Phone
    8004533328
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius