BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ASURAGEN, INC.

    Reg #: 3003436513 · FEI: 3003436513 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    ASURAGEN, INC.
    Registration Number
    3003436513
    FEI Number
    3003436513
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2150 WOODWARD ST, Suite 100
    City
    AUSTIN
    State
    TX
    ZIP
    78744
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN190023

    Owner / Operator

    Firm Name
    ASURAGEN, INC.
    Operator Number
    9049048
    Address
    2150 WOODWARD ST. Suite 100, --
    City
    Austin
    State
    TX
    Postal Code
    78744
    Country
    US
    Correspondent
    Stephanie Mantooth

    Products

    Device Name Product Code
    Inherited Nucleotide Repeat Disorder Dna Test OYV
    Genetic Variant Detection And Health Risk Assessment System PTA
    General Purpose Reagent PPM
    Bcr/Abl1 Monitoring Test OYX
    Tissue Rna Preservative For Collection, Storage, And Transportation OZF

    Proprietary Names

    AmplideX DM-1 Dx Kit AmplideX PCR/CE FMR1 Kit AmplideX SMA Plus Kit ROX 1000 Size Ladder GC-Rich PCR Reagents AmplideX Fragile X Dx & Carrier Screen Test QuantideX® qPCR BCR-ABL minor Kit QuantideX® qPCR BCR-ABL IS Kit RNARetain

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device