BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PerFix NC Kit (Fixative Reagent)

    Reg #: 1034886 · FEI: 1034886 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    53
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BECKMAN COULTER, INC.
    Registration Number
    1034886
    FEI Number
    1034886
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7381 EMPIRE DR.
    City
    FLORENCE
    State
    KY
    ZIP
    41042
    Country
    US

    Owner / Operator

    Firm Name
    BECKMAN COULTER, INC.
    Operator Number
    2050012
    Address
    250 S. Kraemer Blvd, --
    City
    Brea
    State
    CA
    Postal Code
    92821
    Country
    US
    Correspondent
    David G Davis

    Products

    Device Name Product Code
    General Purpose Reagent PPM

    Proprietary Names

    PerFix NC Kit (Fixative Reagent) UniCel DxI Wash Buffer II OnBoard Dilution Kit (A79784 MN MFG) 445865 SYNCHRON Systems Wash Concentrate II 445967 SYNCHRON CX Systems Antifoam 447050 IMMAGE Immunochemistry Systems BUF 3 Buffer 3 472137 SYNCHRON and AU Systems Hemolyzing Reagent 447650 IMMAGE Immunochemistry Systems BUF 1 Buffer 1 447040 IMMAGE Immunochemistry Systems BUF 2 Buffer 2 A28945 SYNCHRON Systems ISE Electrolyte Buffer 447060 IMMAGE Immunochemistry Systems Wash Solution 442831 PVT 2, 472055 PVT 5, 442830 PVT 3 469110 Synchron Systems NO FOAM A28937 SYNCHRON Systems ISE Electrolyte Reference A88469 HbDIL DxC iChem® VELOCITY™ Wash Solution Case of 2 x 7L (800-7217) 657133 Cartridge Chemistry Wash Solution (CCWA 2 x 300) 589784 Trace-Klean Concentrated Cleaning Solution Iris® Diluent Pack (800-3202) 598190 598190 Trace-Klean Ready to Use Cleaning Solution Iris® System Cleanser Pack (800-3203) 447420 IMMAGE Immunochemistry Systems BUF 4 Buffer 4 467826 Sample Diluent 1 DIL1 447660 IMMAGE Immunochemistry Systems DIL 2 Diluent 2 447640 IMMAGE Immunochemistry Systems DIL 1 Diluent 1 GenomeLab GeXP Start Kit DNA Size Standard Kit - 600 Separation Gel – LPAI SEPARATION GEL-LPA I Sample Loading Solution (SLS) DNA Size Standard Kit - 400 DNA Size Standard Kit - 80 CEQ Sample Loading Solution DTCS Quick Start Kit Separation Buffer DNA Sequencing Separation Buffer iQ Lamina 2 x 7L (800-3236) 66039 Cleaning Solution iQ Body Fluids Lysing Reagent (800-3213) iQ Body Fluids Conical Tubes (800-3215) 664090 CLENZ Solution Flow Check Pro Fluorospheres UniCel DxI Access Wash Buffer II (P/N: A16973 KY and DE MFG) Access Substrate (P/N: 81906 MN MFG) Access Wash Buffer II ( P/N: A16972 KY and DE MFG) FLOW-CHECK Access Sample Diluent A (P/N: 81908 MN MFG) LumiPhos PRO Substrate (P/N: B96000 MN MFG) Access Sample Diluent A (Onboard Reagent Kit) (P/N: A79783 MN MFG) OSR62166 LIH DxFLEX Daily QC Fluorospheres 657197 Synchron AUTO-GLOSS CTS ODR2000 5L WASH SOLUTION OSR0001 WASH SOLUTION

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)