BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sudan Black IV Stain

    Reg #: 2022807 · FEI: 2022807 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    29
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HARDY DIAGNOSTICS
    Registration Number
    2022807
    FEI Number
    2022807
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1430 WEST MCCOY LN.
    City
    Orcutt
    State
    CA
    ZIP
    93455
    Country
    US

    Owner / Operator

    Firm Name
    HARDY DIAGNOSTICS
    Operator Number
    2022807
    Address
    1430 West McCoy Lane, --
    City
    Santa Maria
    State
    CA
    Postal Code
    93455
    Country
    US
    Correspondent
    JAY - HARDY

    Products

    Device Name Product Code
    General Purpose Reagent PPM

    Proprietary Names

    Sudan Black IV Stain Potassium Hydroxide 10% TB Digestant, RED SoluPhyte, KOH+DMSO Mayer's Albumin UriStain MucoGest TB Prep Kit Std Sampling Soln TB Prep Kit, RED Triton X-100 10% India Ink Iodine,Dobell & O'Conner NALC Powder Tween 80, 10% Solution Phosphate Buffer Oxalic acid 5% Decolorizer, Slow Water with Tween Sodium Carbonate, 2N HCL,50% Concentr. Sol Deionized Water Potassium Hydroxide, KOH UriStain, 15ml TB Base Digestant Zephiran-TSP Zephiran-TSP w/BTB Ind. MycoMount for wet mounts Sodium Citrte 2.94%

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device