BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    pro-lab incorporated

    Reg #: 8010383 · FEI: 1000354384 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    225
    Establishment Types
    3
    Classifications
    13

    Registration Details

    Registration Name
    pro-lab incorporated
    Registration Number
    8010383
    FEI Number
    1000354384
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    20 Mural Street, Unit #4
    City
    Richmond Hill Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K914419

    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
    Crystal Violet For Histology ICF
    Antisera, All Groups, Salmonella Spp. GRM
    Culture Media, Single Biochemical Test JSF
    Antigens, All Types, Escherichia Coli GMZ
    Antisera, All Types, Shigella Spp. GNB
    Antisera, All Types, Escherichia Coli GNA
    Sampler, Amniotic Fluid (Amniocentesis Tray) HIO
    Discs, Strips And Reagents, Microorganism Differentiation JTO
    Supplement, Culture Media JSK
    Reagents, Antibody, Legionella, Direct & Indirect Fluorescent LHL
    Antisera, Fluorescent, All Types, Staphylococcus Spp. GTN
    Plasma, Coagulase, Human, Horse And Rabbit JTL

    Proprietary Names

    Prolex Streptococcal Grouping Reagent Polyvalent Positive Control Hardy StrepPRO Grouping Kit Prolex Strep Enzyme Polyvalent Positive Control Prolex Strep Group G Enzyme Latex Reagent Prolex Strep Group C Enzyme Latex Reagent Prolex Strep Enzyme Kit Prolex Strep Enzyme Extraction Reagent Prolex Strep Group F Enzyme Latex Reagent Prolex Strep Group A Enzyme Latex Reagent Prolex Strep Group B Enzyme Latex Reagent Prolex Strep Group D Enzyme Latex Reagent BD BBL Streptocard Enzyme Test Latex A BD BBL Streptocard Enzyme Test Latex D BD BBL Streptocard Enzyme Test Latex B BD BBL Streptocard Acid Test Latex D BD BBL Streptocard Acid Test Latex G BD BBL Streptocard Test Cards BD BBL Streptocard Acid Extraction Reagent BD BBL Streptocard Acid Control + BD BBL Streptocard Enzyme Latex Test Kit BD BBL Streptocard Acid Test Latex B BD BBL Streptocard Acid Latex Test Kit BD BBL Streptocard Acid Test Latex C BD BBL Streptocard Enzyme Extraction Reagent Hardy Group C Streptococcal Latex Suspension BD BBL Streptocard Enzyme Test Latex C BD BBL Streptocard Acid Test Latex A BD BBL Streptocard Enzyme Control + BD BBL Streptocard Enzyme Test Latex G BD BBL Streptocard Acid Test Latex F Hardy Reagent 1 For Streptococcal Grouping BD BBL Streptocard Enzyme Test Latex F Hardy Group B Streptococcal Latex Suspension Hardy Group A Streptococcal Latex Suspension Hardy Mixing Sticks (75/PKG) Hardy Reagent 2 For Streptococcal Grouping Hardy Latex Agglutination Test Cards Hardy Group D Streptococcal Latex Suspension Prolex Mixing Sticks Hardy Group F Streptococcal Latex Suspension Hardy Reagent 3 For Streptococcal Grouping Hardy Group G Streptococcal Latex Suspension Prolex Streptococcal Grouping Reagent Extraction Reagent 3 (2 x 8 ml) Prolex Latex Agglutination Test Cards Hardy Polyvalent Positive Control (Strep) Prolex Streptococcal Grouping Reagent Latex Suspension Group C Prolex Streptococcal Grouping Reagent Latex Suspension Group A Prolex Streptococcal Grouping Latex Kit Prolex Extraction Reagent Set Prolex Group A Streptococcal Xtra Latex Reagent Prolex Streptococcal Grouping Reagent Latex Suspension Group D Prolex Group B Streptococcal Xtra Latex Reagent Prolex Streptococcal Grouping Reagent Latex Suspension Group F Prolex Streptococcal Xtra Select Kit Prolex Streptococcal Grouping Reagent Latex Suspension Group G Prolex Streptococcal- Select Grouping Latex Kit Prolex Streptococcal Grouping Reagent Extraction Reagent 2 Agglut'n Cards (48)-ink circle Prolex Streptococcal Grouping Reagent Extraction Reagent 1 Prolex Streptococcal Grouping Reagent Latex Suspension Group B Crystal Violet Monovalent Somatic Salmonella Antisera - Group B/D, Factor 12 Rapid Polyvalent Salmonella Diagnostic Sera RSD 3 Monovalent Somatic Salmonella Antisera - Group B, Factor 5 Monovalent Somatic Salmonella Antisera - Group E, Factor 3, 10, 15, 19, 34 Monovalent Flagella Salmonella Antisera - Factor m Monovalent Flagella Salmonella Antisera - Z4 Complex Monovalent Somatic Salmonella Antisera - Group S, Factor 41 Monovalent Somatic Salmonella Antisera - Group G2, Factor 23 Monovalent Somatic Salmonella Antisera - Group Q, Factor 39 Monovalent Flagella Salmonella Antisera - G Complex Monovalent Somatic Salmonella Antisera - Group J, Factor 17 Monovalent Flagella Salmonella Antisera - Factor gm Monovalent Somatic Salmonella Antisera - Group E4, Factor 19 Monovalent Somatic Salmonella Antisera - Group E1, Factor 10 Monovalent Somatic Salmonella Antisera - Group A, Factor 2 Monovalent Flagella Salmonella Antisera - E Complex eh, enx, enz15 Monovalent Flagella Salmonella Antisera - Factor z15 Monovalent Flagella Salmonella Antisera - Factor 6 Monovalent Flagella Salmonella Antisera - Factor gp Rapid Polyvalent Salmonella Diagnostic Sera RSD 1 Monovalent Flagella Salmonella Antisera - Factor i Monovalent Somatic Salmonella Antisera - Group C2, Factor 8 Monovalent Flagella Salmonella Antisera - Factor 2 Rapid Polyvalent Salmonella Diagnostic Sera RSD 2 Monovalent Somatic Salmonella Antisera - Group F, Factor 11 Monovalent Somatic Salmonella Antisera - Group R, Factor 40 Monovalent Flagella Salmonella Antisera - Factor z28 Monovalent Flagella Salmonella Antisera - Factor f Monovalent Flagella Salmonella Antisera - Factor a Monovalent Somatic Salmonella Antisera - Group M, Factor 28 Monovalent Flagella Salmonella Antisera - Factor d Monovalent Somatic Salmonella Antisera - Group C, Factor 6, 7 Monovalent Flagella Salmonella Antisera - Factor v Monovalent Flagella Salmonella Antisera - Factor z10 Monovalent Somatic Salmonella Antisera - Vi Factor Monovalent Somatic Salmonella Antisera - Group N, Factor 30 Monovalent Flagella Salmonella Antisera - Factor z6 Polyvalent Somatic Salmonella Antisera - Polyvalent O A-S Monovalent Flagella Salmonella Antisera - Factor enz15 Monovalent Flagella Salmonella Antisera - Factor k Monovalent Somatic Salmonella Antisera - Group B, Factor 4 Monovalent Flagella Salmonella Antisera - Factor enx Monovalent Somatic Salmonella Antisera - Factor 55 Monovalent Flagella Salmonella Antisera - Factors l, w Monovalent Flagella Salmonella Antisera - Factor h Monovalent Somatic Salmonella Antisera - Group D, Factor 9 Polyvalent Somatic Salmonella Antisera - Polyvalent O A-1+Vi Monovalent Somatic Salmonella Antisera - Group E2, Factor 15 Monovalent Flagella Salmonella Antisera - Factor s Monovalent Flagella Salmonella Antisera - Factor z32 Monovalent Somatic Salmonella Antisera - Group O, Factor 35 Monovalent Flagella Salmonella Antisera - Factor z13 Monovalent Flagella Salmonella Antisera - Factor z29 Monovalent Flagella Salmonella Antisera - Factor 7 Monovalent Flagella Salmonella Antisera - Factor p Monovalent Flagella Salmonella Antisera - Factor 5 Monovalent Somatic Salmonella Antisera - Group P, Factor 38 Monovalent Flagella Salmonella Antisera - L Complex Monovalent Flagella Salmonella Antisera - Factor r Monovalent Flagella Salmonella Antisera - Factor w Monovalent Flagella Salmonella Antisera - Factor z24 Monovalent Flagella Salmonella Antisera - Factor b Monovalent Flagella Salmonella Antisera - Factor z Polyvalent Flagella Salmonella Antisera - H Phase 2, Factors 1, 2, 5, 6, 7, z6 Monovalent Somatic Salmonella Antisera - Group G1, Factor 22 Monovalent Flagella Salmonella Antisera - Factor c Monovalent Flagella Salmonella Antisera - Factor eh Monovalent Flagella Salmonella Antisera - Factor q Monovalent Somatic Salmonella Antisera - Group E3, Factor 34 Monovalent Flagella Salmonella Antisera - Factor u Monovalent Somatic Salmonella Antisera - Group K, Factor 18 Monovalent Flagella Salmonella Antisera - Factors l, v Monovalent Flagella Salmonella Antisera - Factor y Monovalent Somatic Salmonella Antisera - Group C3, Factor 20 Monovalent Somatic Salmonella Antisera - Group L, Factor 21 Monovalent Flagella Salmonella Antisera - Factor z23 Monovalent Somatic Salmonella Antisera - Group G, Factor 13, 22, 23 Polyvalent Flagella Salmonella Antisera - H Phase 1 & 2 Monovalent Somatic Salmonella Antisera - Group I, Factor 16 Spot Indole Reagent (10ml) Prolex E. coli O157 Latex Test Reagent Kit (50 Tests) Prolex E. coli 0157 Latex Reagent Control Negative Prolex E. coli O157 Latex Test Reagent Kit (100 Tests) Hardy E. coliPRO O157 Kit Polyvalent Shigella Slide Antisera - dysenteriae 1-10 Polyvalent Shigella Slide Antisera - sonnei Phase 1 & 2 Polyvalent Shigella Slide Antisera - boydii 1-15 Polyvalent Shigella Slide Antisera - flexneri 1-6 X & Y Prolex E. coli O157 Latex Test Reagent Kit (50 tests) Prolex E. coli O157 Latex Reagent Control Negative Prolex E. coli O111 Latex Reagent Prolex E. coli O103 Latex Reagent Prolex E. coli O121 Latex Reagent Prolex E. coli Non-O157 Negative Control Latex Reagent Prolex E. coli O91 Latex Reagent Prolex E. coli O145 Latex Reagent Prolex E. coli O157 Latex Test Reagent Kit (100 tests) Prolex E. coli O26 Latex Reagent Prolex E. coli Non-O157 Identification Kit Prolex E. coli O45 Latex Reagent E. coli O157 Antiserum (3ml) AmnioTest (20 Pack) AmnioTest (100 pack) Bulk dipped AmnioTest swabs AmnioTest Colour Cards Kovac's Reagent (100ml) TestOxidase Reagent (125ml) TestOxidase Reagent (15ml) Mucolyse Legionella DFA Negative Control Legionella pneumophila Serogroup 12 DFA Reagent Legionella pneumophila Serogroup 1 DFA Kit (50 tests) Legionella pneumophila Serogroup 11 DFA Reagent Prolex Legionella pneumophila Serogroup 5 Latex Reagent Legionella pneumophila Serogroup 9 DFA Reagent Prolex Legionella pneumophila Serogroup 2 Latex Reagent Legionella pneumophila Serogroup 7 DFA Reagent Legionella pneumophila Serogroup 4 DFA Reagent Legionella pneumophila Serogroup 5 DFA Reagent Prolex Legionella pneumophila Serogroup 4 Latex Reagent Legionella pneumophila Serogroup 6 DFA Reagent Legionella micdadei DFA Reagent Legionella pneumophila Serogroup 8 DFA Reagent Prolex Legionella pneumophila Serogroup 1 Latex Reagent (Monoclonal) Prolex Legionella pneumophila Serogroup 14 Latex Reagent Prolex Legionella pneumophila Serogroup 3 Latex Reagent Legionella pneumophila Serogroup 10 DFA Reagent Prolex Legionella pneumophila Serogroup 6 Latex Reagent Prolex Legionella pneumophila Serogroup 7 Latex Reagent Prolex Legionella pneumophila Serogroup 8 Latex Reagent Prolex Legionella pneumophila Serogroup 10 Latex Reagent Prolex Legionella pneumophila Serogroup 11 Latex Reagent Legionella pneumophila Serogroup 2 DFA Reagent Legionella DFA Mounting Medium Legionella pneumophila Serogroups 1-14 DFA Kit (50 tests) Prolex Legionella pneumophila Negative Control Latex Reagent Prolex Legionella pneumophila Serogroup 13 Latex Reagent Phosphate Buffered Saline (pH 7.6) Prolex Legionella pneumophila Serogroups 1-14 Positive Control Prolex Legionella pneumophila Serogroup 9 Latex Reagent Legionella pneumophila Positive Control Serogroups 1-14 Prolex Legionella pneumophila Serogroup 12 Latex Reagent Legionella pneumophila Serogroup 14 DFA Reagent Legionella pneumophila Serogroup 13 DFA Reagent Prolex L. pneumophila Serogroup 1 Positive Control Latex Reagent Legionella pneumophila Serogroup 3 DFA Reagent Prolex L. pneumophila Serogroup 1 Negative Control Latex Reagent Prolex Legionella micdadei Prolex Staph Positive Control Prolex Staph Xtra Latex Kit (300 tests) BD BBL Staphyloside Latex Test Kit (500 tests) BD BBL Staphyloside Latex Test Kit (100 tests) Hardy StaphTEX Kit (1000 tests) Hardy StaphTEX Kit (50 tests) Prolex Staph Xtra Latex Kit (100 tests) Prolex Latex Reagent Control Negative (StaphXtra) Prolex Staph Kit (300 Tests) Prolex Latex Reagent Control Negative (Staph) Prolex Staph Kit (100 tests) Hardy StaphTEX Kit (200 tests) Rabbit Coagulase Plasma (1x20ml) Rabbit Coagulase Plasma (10x3ml) Rabbit Coagulase Plasma (1x10ml) Rabbit Coagulase Plasma (1x30ml)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device