BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ENTROGEN, INC

    Reg #: 3010791816 · FEI: 3010791816 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    47
    Establishment Types
    3
    Classifications
    2

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    Registration Details

    Registration Name
    ENTROGEN, INC
    Registration Number
    3010791816
    FEI Number
    3010791816
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    20950 Warner Center Lane, Suite B
    City
    Woodland Hills
    State
    CA
    ZIP
    91367
    Country
    US

    Regulatory Submissions

    PMA Number
    P220005

    Owner / Operator

    Firm Name
    EntroGen, Inc
    Operator Number
    10088140
    Address
    20950 Warner Center Lane, Suite B
    City
    Woodland Hills
    State
    CA
    Postal Code
    91367
    Country
    US
    Correspondent
    Gary Potikyan

    Products

    Device Name Product Code
    Somatic Gene Mutation Detection System OWD
    Clinical Sample Concentrator JJH

    Proprietary Names

    IDH-RT38 IDH1/2 Mutation Detection Kit EGFRX-RT52 EGFRX Mutation Analysis Kit EGFRV3-RT42 EGFRvIII Detection Kit CKIT-RT44 c-Kit Mutation Detection Kit RASX-RT50 RAS c.59/117 Mutation Detection Kit THRNA-RT32 Thyroid Cancer Fusion Gene Detection Kit LEUK3-QRT24 MLL-AF4 One-Step Detection Kit LUNG-RT48 Lung Cancer RNA Panel THDNA-RT64 Thyroid Cancer Mutation Detection Kit RAS-RT50 RAS Mutation Analysis Kit CFDNA-50 pureNA® Cell-Free DNA Isolation Kit LEUK2-QRT24 E2A-PBX1 One-Step Detection Kit BCR190-QRT46 BCR-ABL P190 (mbcr) One-Step Detection Kit BRCA-NGS BRCA Complete™ GIST-RT44 GIST Mutation Detection Kit NGS-LIG NGS Library Prep Kit For Illumina LEUK4-QRT24 PML-RARA bcr1, bcr2, bcr3 One-Step Detection Kit BCR210-AQSTD BCR-ABL P210 Quantitative Control Standards BCR210-QRT46 BCR-ABL P210 (Mbcr) One-Step Detection Kit CTRAS-RT40 ctDNA RAS Mutation Detection Kit FQA-RT40 DNA Fragmentation Quantification Assay BRAFX-RT64 BRAF Codon 600 Mutation Analysis Kit II KRAS-RT50 KRAS Mutation Analysis Kit LEUK6-QRT24 CBFb-MYH11 One-Step Detection Kit CTBRAF-48 ctDNA BRAF V600 Mutation Detection Kit PI3K-RT48 PIK3CA Mutation Analysis Kit GDNA-50 pureNA® Genomic DNA Isolation Kit LEUKMP-RT24 Leukemia Translocation Panel V2 NGS-BDS Library Prep Purification Kit EGFR-RT52 EGFR Mutation Analysis Kit CTEGFR-48 ctDNA EGFR Mutation Detection Kit BCK-RT50 Bisulfite Conversion Kit UGT-RT50 UGT1A1 Genotyping Kit IQCA-RT50 Internal Quality Control Assay NRAS-RT50 NRAS Mutation Analysis Kit MGMT-RT44 MGMT Methylation Detection Kit MLH1-RT24 MLH1 Methylation Detection Kit LEUK5-QRT24 TEL-AML1 One-Step Detection Kit NGS-ADP NGS Adapter Kit for Illumina KRBR-RT50 KRAS/BRAF Mutation Analysis Kit LEUK1-QRT24 AML1-ETO One-Step Detection Kit BRCAX-NGS BRCA Complete™ Expanded Panel LIBQ-NGS Library Quantification Kit for Illumina THSP-ILNGS NGS Targeted Hotspot Panel CRC-RT48 Colorectal Cancer Mutation Detection Panel CRCdx RAS Mutation Detection Kit BenchBot 4800 Liquid Handling System

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility