BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    CatchGene Dx Circulating cfRNA 1000 Kit

    Reg #: 3010030414 · FEI: 3010030414 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIOPTIC INC.
    Registration Number
    3010030414
    FEI Number
    3010030414
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4F., No.108-3 & No. 108-4,Minquan Rd., Xindian Dist.
    City
    New Taipei
    Country
    TW

    Owner / Operator

    Firm Name
    BiOptic Inc.
    Operator Number
    10086887
    Address
    4F., No.108-3 & No. 108-4,Minquan Rd., Xindian Dist.
    City
    New Taipei
    State
    TW-NWT
    Postal Code
    23141
    Country
    TW
    Correspondent
    Yutien Huang

    Products

    Device Name Product Code
    Clinical Sample Concentrator JJH

    Proprietary Names

    CatchGene Dx Circulating cfRNA 1000 Kit CatchGene Dx Catch-cfDNA Serum/Plasma Kit(1000/4000/M4000); CatchGene Dx Catch-cfDNA Urine Kit iCATCHER Dx Circulating cfRNA Kit(1000/2000/4000) CatchGene Dx DNA Kit(Cell/Blood/Saliva/Tissue/FFPE Tissue/Stool/Microbiome/Oil) CatchGene Dx RNA Kit (Cell/Tissue/FFPE Tissue/Blood/Ultra Blood/Viral/One Cell) CatchGene Dx DNA/RNA Kit (Viral/Ultra Viral/Exosome/FFPE Tissus) CatchGene Dx Circulating cfDNA/cfRNA Kit(1000/4000) CatchGene Dx miRNA Kit (Cell/Exosome/Tissue/FFPE Tissue); CatchGene Dx Catch-miRNA Serum/Plasma Kit iCATCHER Dx DNA Kit(250/1000/4000), iCATCHER Dx Tissue DNA Kit(250/4000), iCATCHER Dx FFPE Tissue DNA Kit, iCATCHER Dx Stool DNA Kit(250/1000/4000) iCATCHER Dx Tissue miRNA Kit, iCATCHER Dx FFPE Tissue miRNA Kit iCATCHER Dx Blood RNA 1000 Kit, iCATCHER Dx Tissue RNA 1000 Kit, iCATCHER Dx FFPE Tissue RNA Kit iCATCHER Dx Circulating cfDNA/cfRNA Kit(1000/2000/4000) iCATCHER Dx VB DNA/RNA Kit (250/1000), iCATCHER Dx FFPE Tissue DNA/RNA Kit; iCATCHER Dx Circulating cfDNA Kit(1000/2000/4000) iCATCHER Dx Circulating cfDNA Kit(1000/2000/4000) iCATCHER 12 Dx Automated Nucleic Acid Purification System

    Establishment Types

    Manufacture Medical Device