BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOCHEMICAL DIAGNOSTICS, INC.

    Reg #: 2432495 · FEI: 2432495 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    22
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    BIOCHEMICAL DIAGNOSTICS, INC.
    Registration Number
    2432495
    FEI Number
    2432495
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    180 HEARTLAND BLVD.
    City
    Edgewood
    State
    NY
    ZIP
    11717
    Country
    US

    Regulatory Submissions

    510(k) Number
    K925586

    Owner / Operator

    Firm Name
    BIOCHEMICAL DIAGNOSTICS, INC.
    Operator Number
    2432495
    Address
    37 Birch Street, --
    City
    Milford
    State
    MA
    Postal Code
    01757
    Country
    US
    Correspondent
    David - Larrivee

    Products

    Device Name Product Code
    Multi-Analyte Controls Unassayed OHQ
    Drug Mixture Control Materials DIF
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    DETECTABUSE PREGNANCY-SKREEN Detectabuse Liquid Control Salivabuse Liquid Oral Fluid Control Kova POC Pregnancy-Skreen hCG Serum Detectabuse STAT-SKREEN-H STAT-SKREEN-H with MDMA, OXY & BUP STAT-SKREEN DOA-SKREEN-H STAT-SKREEN 17H STAT-SKREEN 17 DOA-SKREEN STAT-SKREEN with MDMA, OXY & BUP AU/NZ SKREEN Fentanyl 2x5mL kitbox AU NZ SKREEN23 STAT-SKREEN25H STAT-SKREEN 23, STAT-SKREEN 23H Toxicology Evaluation Panel II STAT-SKREEN25 AU/NZ SKREEN23

    Establishment Types

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