BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Advanced Cell Diagnostics, Inc.

    Reg #: 3009161685 · FEI: 3009161685 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    22
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Advanced Cell Diagnostics, Inc.
    Registration Number
    3009161685
    FEI Number
    3009161685
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7707 Gateway Blvd, Suite 200
    City
    Newark
    State
    CA
    ZIP
    94560
    Country
    US

    Owner / Operator

    Firm Name
    Advanced Cell Diagnostics
    Operator Number
    10051491
    Address
    7707 Gateway
    City
    Newark
    State
    CA
    Postal Code
    94560
    Country
    US
    Correspondent
    Bob Li

    Products

    Device Name Product Code
    Reagents, Specific, Analyte MVU
    General Purpose Reagent PPM

    Proprietary Names

    ACD RNA ISH Probe HPV-6 ACD RNA ISH Probe (concentrate) HPV-33 ACD RNA ISH Probe (concentrate) HPV-31 ACD RNA ISH Probe (concentrate) HPV-11 ACD RNA ISH Probe UBC (Positive Control) ACD RNA ISH Probe PPIB (Positive Control) ACD RNA ISH Probe Albumin ACD RNA ISH Probe EBV ACD RNA ISH Probe Napsin A ACD RNA ISH Probe (concentrate) HPV-18 RNAscope™ ISH Probe SARS-CoV-2 ACD RNA ISH Probe TTF-1 (Thyroid Transcription Factor-1) ACD RNA ISH Probe DapB (Negative Control) ACD RNA ISH Probe CMV ACD RNA ISH Probe HPV-31 ACD RNA ISH Probe HPV-16 RNAscope™ ISH Probe IGLL5 RNAscope™ ISH Probe Kappa RNAscope™ ISH Probe Lambda BOND RNAscope® Protease BOND RNAscope® Detection Reagents-BROWN BOND-PRIME® RNAscope® Brown Detection System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device