BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Epredia

    DI: 00673693483315 · Model: Clarifier™ 2 · RICHARD-ALLAN SCIENTIFIC COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Epredia
    Primary DI
    00673693483315
    Version / Model
    Clarifier™ 2
    Catalog Number
    7402L
    Company Name
    RICHARD-ALLAN SCIENTIFIC COMPANY
    Labeler DUNS
    929504710
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-08-30
    Public Version
    1
    Public Version Date
    2024-09-09
    Public Version Status
    New
    Public Device Record Key
    c52b0aa9-16a5-4dcc-a125-92c88a12df00

    Device Description

    Clarifier™ 2 is an aqueous glacial acetic acid rinse designed to eliminate background staining sometimes caused by excessive adhesives in the water bath such as gelatin. Clarifier™ 2 selectively removes hematoxylin staining from excess adhesive without affecting nuclear staining. This product is only effective with progressive staining an should not be used with regressive stains. Clarifier 2 was designed to be used in histology only. Clarifier™ 2 is designed for use after staining with progressive hematoxylins. After tissues have been sufficiently stained with a progressive hematoxylin, slides are removed from the stain and excess hematoxylin is removed by rinsing the sections in water. The sections are then placed into Clarifier™ 2 for 20 seconds to 40 seconds. A 1-minute water rinse should follow as this stops the reaction and rinses excess acid from the tissue section.

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LED Stains, Chemical Solution

    GMDN Terms

    Code Name
    43584 Acid-alcohol solution IVD

    Identifiers

    Type ID
    Primary 00673693483315