BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TintoEDTA, 1L

    DI: B502BSB74600 · Model: BSB-7460 · BIO SB, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    TintoEDTA, 1L
    Primary DI
    B502BSB74600
    Version / Model
    BSB-7460
    Catalog Number
    BSB-7460
    Company Name
    BIO SB, INC.
    Labeler DUNS
    102855447
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-03-18
    Public Version
    1
    Public Version Date
    2025-03-26
    Public Version Status
    New
    Public Device Record Key
    4904b574-d8a0-4b36-9ef5-5b0b7d8ae0f4

    Device Description

    TintoEDTA is intended to be used with heat-induced epitope or nucleic acid retrieval procedures to permeabilize tissues for Immunohistochemistry (IHC), Immunocytochemistry (ICC), Immunofluorescence (IF) and in situ hybridization (ISH) of nucleic acids (both CISH or FISH) on the TintoStainer Plus automated platform.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PPM General purpose reagent

    GMDN Terms

    Code Name
    57770 Immunohistochemistry antigen retrieval reagent IVD

    Identifiers

    Type ID
    Primary B502BSB74600

    Customer Contacts

    Phone
    +1(800)561-1145
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Total Volume 1000 Milliliter

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    20 – 25 Degrees Celsius