BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AU/NZ SKREEN23

    Reg #: 2432495 · FEI: 2432495 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    BIOCHEMICAL DIAGNOSTICS, INC.
    Registration Number
    2432495
    FEI Number
    2432495
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    180 HEARTLAND BLVD.
    City
    Edgewood
    State
    NY
    ZIP
    11717
    Country
    US

    Regulatory Submissions

    510(k) Number
    K153474

    Owner / Operator

    Firm Name
    BIOCHEMICAL DIAGNOSTICS, INC.
    Operator Number
    2432495
    Address
    180 HEARTLAND BLVD., --
    City
    Edgewood
    State
    NY
    Postal Code
    11717
    Country
    US
    Correspondent
    Gary - Padron

    Products

    Device Name Product Code
    Drug Mixture Control Materials DIF

    Proprietary Names

    AU/NZ SKREEN23 Fentanyl 2x5mL kitbox AU/NZ SKREEN Toxicology Evaluation Panel II AU NZ SKREEN23 Detectabuse DOA-SKREEN-H STAT-SKREEN 17H STAT-SKREEN 17 STAT-SKREEN-H DOA-SKREEN STAT-SKREEN with MDMA, OXY & BUP STAT-SKREEN-H with MDMA, OXY & BUP STAT-SKREEN STAT-SKREEN 23, STAT-SKREEN 23H STAT-SKREEN25 STAT-SKREEN25H

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device