BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    QuantStudio™ 7 Pro Dx Software

    Reg #: 3003673482 · FEI: 3003673482 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    31
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Life Technologies Holdings Pte Ltd.
    Registration Number
    3003673482
    FEI Number
    3003673482
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BLK 33, MARSILING INDUSTRIAL, ESTATE ROAD 3, No. 07-06
    City
    SINGAPORE North West
    Country
    SG

    Owner / Operator

    Firm Name
    Life Technologies Corporation
    Operator Number
    9915045
    Address
    5781 Van Allen Way, --
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US

    Products

    Device Name Product Code
    Real Time Nucleic Acid Amplification System OOI

    Proprietary Names

    QuantStudio™ 7 Pro Dx Software 384-Well Spectral Calibration Plate 1 (FAM™, VIC™, ROX™, SYBR™, TAMRA™ Dyes) 96-Well 0.2-mL Calibration Plate 2 (ABY, JUN, and MUSTANG PURPLE dyes) 384-Well Normalization plates with FAM/ROX and VIC/ROX Dyes 384-Well Spectral Calibration plate with TAMRA Dye 384 Well Spectral Calibration plate with ROX Dye 384-Well Spectral Calibration Plate 2 (ABY™, JUN™, MUSTANG PURPLE™, NEO™, Cy®5 Dyes) Rnase P Fast 384-Well Instrument Verification Plate 96-Well 0.2-mL Calibration Plate 3 (TAMRA, NED, and Cy 5 dyes) 384-Well 10-Dye Calibration Kit 96-Well Region of Interest (ROI) and Background Plates Diomini™ Software QuantStudio™ 7 Pro Dx 96-Well Block RNase P 96-Well Instrument Verification Plate RNase P 384-Well Instrument Verification Plate Quantstudio Dx 384-Well CE-IVD 384-Well Region of Interest (ROI) and Background Plates 384-Well Spectral Calibration plate with VIC Dye 96-Well Spectral Calibration Plate with Alexa Fluor 647 Dye QuantStudio™ 7 Pro Dx 96-Well Heated Cover Quantstudio™ 7 Pro Dx 384-Well Heated Cover 384-Well Background Calibration Plate 384-Well Spectral Calibration plate with FAM Dye Quantstudio™ 7 Pro Dx 384-Well Block 96-Well 0.2-mL Spectral Calibration Plate 1 (FAM, VIC, ROX, and SYBR Dyes) Standard 96-well 10-Dye Calibration Kit Fast 96-Well Spectral Calibration Plate with Alexa Fluor 647 Dye Applied Biosystems™ QuantStudio™ 5 Dx Real-Time PCR Instrument (96 Well 0.2mL Block) FAST 96-Well Region of Interest (ROI) and Background Plates QuantStudio™ 7 Pro Dx Real-Time PCR Instrument QuantStudio™ 5 Dx Software

    Establishment Types

    Manufacture Medical Device