BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Takara Bio USA, Inc.

    Reg #: 1000231747 · FEI: 1000231747 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Takara Bio USA, Inc.
    Registration Number
    1000231747
    FEI Number
    1000231747
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2560 Orchard Parkway
    City
    San Jose
    State
    CA
    ZIP
    95131
    Country
    US

    Owner / Operator

    Firm Name
    Takara Bio USA, Inc.
    Operator Number
    10049222
    Address
    2560 Orchard Parkway
    City
    San Jose
    State
    CA
    Postal Code
    95131
    Country
    US
    Correspondent
    Loretta L Momme

    Products

    Device Name Product Code
    General Purpose Reagent PPM

    Proprietary Names

    5X PrimePath™ Probe qPCR Kit, no ROX, 200 rxns Lyo-Ready PrimePath™ Probe qPCR Mix, 100 rxns MMLV Reverse Transcriptase, 2000 Units MMLV Reverse Transcriptase, 20000 Units 5X PrimePath™ Probe qPCR Kit, ROX plus, 1000 rxns 5X One Step PrimeScript™ III RT-qPCR Kit, ROX plus, 1000 rxns 5X One Step PrimeScript™ III RT-qPCR Kit, no ROX, 200 rxns 5X One Step PrimeScript™ III RT-qPCR Kit, no ROX, 1000 rxns 5X One Step PrimeScript™ III RT-qPCR Kit, ROX plus, 200 rxns 5X PrimePath™ Probe qPCR Kit, ROX plus, 200 rxns MMLV Reverse Transcriptase, 8000 Units 5X PrimePath™ Probe qPCR Kit, no ROX, 1000 rxns

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device