BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    BIOPTIC INC.

    Reg #: 3010030414 · FEI: 3010030414 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    24
    Establishment Types
    1
    Classifications
    5

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    Registration Details

    Registration Name
    BIOPTIC INC.
    Registration Number
    3010030414
    FEI Number
    3010030414
    Status
    Active
    Expiry Year
    2026
    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
    Thermocycler, Generic OUL
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Apparatus, Electrophoresis, For Clinical Use JJN
    General Purpose Reagent PPM
    Clinical Sample Concentrator JJH

    Proprietary Names

    Qamp mini Thermal cycler LV Module (30/100 sets); 1mm Beads Tube (36/50/250 pcs); 3mm Beads Tube (36/50/250 pcs) Elution Tube (36/50 pcs); EtOH Tube (36/50 pcs); Sample Tube (36/50 pcs); Syringe (36/50 pcs); Tip Set (36/50 pcs) Micro Vial; Sample tray; Buffer tray; Droppers; PCR tubes; 16+3-well Sample Tube; Rotor plate (for 16+3 tube) DNA Cartridges (S1, S2, S3, F3, N1, N3, L1, L2, L3); RNA Cartridges (R1, NR1, LR1); Protein Cartridges (P2); Quantitative Cartridge Kit; Quantitative marker; Alignment Marker; Size Marker; Separation Buffer; Dilution Buffer; Mineral Oil; Power Supply; Air Pump; Purge Station Qsep Series Bio-Fragment Analyzer (Qsep1, Qsep1-Lite, Qsep1-Plus; Qsep100, Qsep100 Advance; Qsep400; Qsep400 SE; Qsep400 Advance; QsepUltra); Proteinase K (1/11/50/100/130 mg); Carrier RNA (12/140/200 ug); Buffer DWX (50/100/200 mL) iCATCHER Dx Blood RNA 1000 Kit, iCATCHER Dx Tissue RNA 1000 Kit, iCATCHER Dx FFPE Tissue RNA Kit CatchGene Dx Circulating cfDNA/cfRNA Kit(1000/4000) CatchGene Dx Catch-cfDNA Serum/Plasma Kit(1000/4000/M4000); CatchGene Dx Catch-cfDNA Urine Kit iCATCHER Dx Circulating cfRNA Kit(1000/2000/4000) 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) CatchGene Dx miRNA Kit (Cell/Exosome/Tissue/FFPE Tissue); CatchGene Dx Catch-miRNA Serum/Plasma Kit CatchGene Dx RNA Kit (Cell/Tissue/FFPE Tissue/Blood/Ultra Blood/Viral/One Cell) iCATCHER Dx Circulating cfDNA/cfRNA Kit(1000/2000/4000) CatchGene Dx DNA Kit(Cell/Blood/Saliva/Tissue/FFPE Tissue/Stool/Microbiome/Oil) iCATCHER Dx Circulating cfDNA Kit(1000/2000/4000) CatchGene Dx DNA/RNA Kit (Viral/Ultra Viral/Exosome/FFPE Tissus) iCATCHER Dx Tissue miRNA Kit, iCATCHER Dx FFPE Tissue miRNA Kit iCATCHER 12 Dx Automated Nucleic Acid Purification System iCATCHER Dx VB DNA/RNA Kit (250/1000), iCATCHER Dx FFPE Tissue DNA/RNA Kit; iCATCHER Dx Circulating cfDNA Kit(1000/2000/4000) CatchGene Dx Circulating cfRNA 1000 Kit

    Establishment Types

    Manufacture Medical Device