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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Epredia

    DI: 00673693169080 · Model: Differentiating Solution · 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
    00673693169080
    Version / Model
    Differentiating Solution
    Catalog Number
    88117
    Company Name
    RICHARD-ALLAN SCIENTIFIC COMPANY
    Labeler DUNS
    929504710
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-08-07
    Public Version
    1
    Public Version Date
    2024-08-15
    Public Version Status
    New
    Public Device Record Key
    4d49b586-19e0-4338-971d-63e1f48af101

    Device Description

    "The Acid Fast Bacillus Stain Kit (87016) and components are for use as a kit in special stain techniques to detect acid fast bacteria. A waxy, lipid-rich cell wall surrounds the acid fast bacterium. This cell wall absorbs carbol fuchsin but is resistant to decoloration with acid alcohol. Bacteria that do not have a lipid-rich cell wall easily decolorize leaving the acid fast bacillus. Loeffler Methylene Blue Stain Solution provides a light blue counterstain to provide contrast for surrounding tissue elements from the brick red acid fast bacillus."

    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
    JTS Stains, Microbiologic

    GMDN Terms

    Code Name
    43584 Acid-alcohol solution IVD

    Identifiers

    Type ID
    Primary 00673693169080