Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010383

FEI Number

1000354384

Entity Name

pro-lab incorporated

City/State/Country

Richmond Hill Ontario, CA

Establishment Address

20 Mural Street, Unit #4, Richmond Hill Ontario L4B 1K3, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PRO-LAB, INC. (Owner Number: 8010383)

Owner / Operator Contact Address

20 MURAL ST., UNIT #4, RICHMOND HILL,, CA-ON L4B 1K3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	1994-05-02
ICF	Crystal Violet For Histology	Hematology	Class 1	864.1850	2022-04-06
GRM	Antisera, All Groups, Salmonella Spp.	Microbiology	Class 2	866.3550	2009-08-10
JSF	Culture Media, Single Biochemical Test	Microbiology	Class 1	866.2320	2008-12-02
GMZ	Antigens, All Types, Escherichia Coli	Microbiology	Class 1	866.3255	2001-08-09
GNB	Antisera, All Types, Shigella Spp.	Microbiology	Class 2	866.3660	2008-05-08
GNA	Antisera, All Types, Escherichia Coli	Microbiology	Class 1	866.3255	1994-05-02
HIO	Sampler, Amniotic Fluid (Amniocentesis Tray)	Obstetrics/Gynecology	Class 1	884.1550	2006-04-13
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	1994-05-02
JSK	Supplement, Culture Media	Microbiology	Class 1	866.2450	2001-08-09
LHL	Reagents, Antibody, Legionella, Direct & Indirect Fluorescent	Microbiology	Class 2	866.3300	2001-08-09
GTN	Antisera, Fluorescent, All Types, Staphylococcus Spp.	Microbiology	Class 1	866.3700	2001-08-09
JTL	Plasma, Coagulase, Human, Horse And Rabbit	Microbiology	Class 1	866.2160	2007-11-15

Official Correspondent

No official correspondent registered.

US Agent Details

Robert J Rae Business: Pro-Lab Incorporated Email: rjrae@pro-lab.com Phone: (512) 8329145

Related Public Records

Same Entity

PRO-LAB, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K822995	Granite Diagnostics, Inc.	ANDRADES FERMENTATION MEDIA	1982-11-16
K880126	Hardy Media	LAURYL TRYPTOSE BROTH	1988-03-31
K821594	Hardy Media	UREA AGAR SLANT	1982-07-08
K770926	Analytical Products, Inc.	SUSPENSION SALINE, API 20E	1977-06-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010383. Last updated year: 2026. Please use registration number 8010383 when referencing this establishment in official correspondence.