BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Prolex Streptococcal Grouping Reagent Latex Suspension Group A

    Reg #: 8010383 · FEI: 1000354384 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    60
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    pro-lab incorporated
    Registration Number
    8010383
    FEI Number
    1000354384
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    20 Mural Street, Unit #4
    City
    Richmond Hill Ontario
    Country
    CA

    Owner / Operator

    Firm Name
    PRO-LAB, INC.
    Operator Number
    8010383
    Address
    20 MURAL ST., UNIT #4
    City
    RICHMOND HILL,
    State
    Ontario
    Postal Code
    L4B 1K3
    Country
    CA

    US Agent

    Business Name
    Pro-Lab Incorporated
    Contact Name
    Robert J Rae
    Address
    1301 Blue Ridge Dr, Suite 101
    City
    Georgetown
    State
    TX
    ZIP
    78626
    Country
    US
    Email
    [email protected]
    Phone
    512 8329145

    Products

    Device Name Product Code
    Antisera, All Groups, Streptococcus Spp. GTZ

    Proprietary Names

    Prolex Streptococcal Grouping Reagent Latex Suspension Group A Prolex Streptococcal Grouping Reagent Extraction Reagent 2 Agglut'n Cards (48)-ink circle Hardy StrepPRO Grouping Kit Prolex Streptococcal Grouping Reagent Latex Suspension Group C Prolex Latex Agglutination Test Cards Prolex Group B Streptococcal Xtra Latex Reagent Prolex Strep Enzyme Extraction Reagent Prolex Strep Group G Enzyme Latex Reagent Prolex Strep Group A Enzyme Latex Reagent Prolex Strep Group D Enzyme Latex Reagent Prolex Strep Group C Enzyme Latex Reagent Prolex Strep Group F Enzyme Latex Reagent Prolex Strep Enzyme Kit Prolex Strep Group B Enzyme Latex Reagent Prolex Strep Enzyme Polyvalent Positive Control BD BBL Streptocard Acid Test Latex G BD BBL Streptocard Enzyme Latex Test Kit BD BBL Streptocard Acid Latex Test Kit BD BBL Streptocard Enzyme Test Latex D BD BBL Streptocard Acid Control + BD BBL Streptocard Acid Extraction Reagent BD BBL Streptocard Acid Test Latex C BD BBL Streptocard Enzyme Test Latex A BD BBL Streptocard Enzyme Extraction Reagent Hardy Group C Streptococcal Latex Suspension BD BBL Streptocard Acid Test Latex D BD BBL Streptocard Enzyme Test Latex C BD BBL Streptocard Test Cards BD BBL Streptocard Enzyme Test Latex B BD BBL Streptocard Acid Test Latex B BD BBL Streptocard Enzyme Test Latex G Hardy Reagent 3 For Streptococcal Grouping BD BBL Streptocard Acid Test Latex F Hardy Group G Streptococcal Latex Suspension BD BBL Streptocard Enzyme Control + Hardy Group F Streptococcal Latex Suspension BD BBL Streptocard Acid Test Latex A BD BBL Streptocard Enzyme Test Latex F Hardy Group A Streptococcal Latex Suspension Hardy Reagent 2 For Streptococcal Grouping Hardy Latex Agglutination Test Cards Prolex Mixing Sticks Hardy Reagent 1 For Streptococcal Grouping Hardy Group D Streptococcal Latex Suspension Hardy Group B Streptococcal Latex Suspension Hardy Mixing Sticks (75/PKG) Prolex Streptococcal Grouping Reagent Latex Suspension Group G Prolex Streptococcal Grouping Reagent Extraction Reagent 3 (2 x 8 ml) Prolex Streptococcal Grouping Reagent Latex Suspension Group F Prolex Streptococcal- Select Grouping Latex Kit Prolex Streptococcal Xtra Select Kit Prolex Streptococcal Grouping Latex Kit Prolex Streptococcal Grouping Reagent Latex Suspension Group D Prolex Streptococcal Grouping Reagent Latex Suspension Group B Prolex Streptococcal Grouping Reagent Extraction Reagent 1 Hardy Polyvalent Positive Control (Strep) Prolex Streptococcal Grouping Reagent Polyvalent Positive Control Prolex Group A Streptococcal Xtra Latex Reagent Prolex Extraction Reagent Set

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)