Home GUDID 10628429000271 Prolex Streptococcal Grouping Reagent Polyvalent Positive Control
Primary DI 10628429000271
Brand Prolex Streptococcal Grouping Reagent Polyvalent Positive Control
Company PRO-LAB, INCORPORATED
Model PL.040
Catalog number PL.040
Device description StrepPRO™ Positive Control, for the rapid latex agglutination test, 60 tests Positive Control for the rapid latex agglutination test for the identification of streptococcal groups.
Published 2022-12-25
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name GTZ Antisera, All Groups, Streptococcus Spp.
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GTZ Antisera, All Groups, Streptococcus Spp. Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10628429000271 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10628429000271 10628429000271
Regulatory Flags# DUNS number 960418395 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10628429001223 AmnioTest (Nitrazine yellow swab) PL.901 PL.901 2022-12-26 20628429001220 AmnioTest (Nitrazine yellow swab 20 box) PL.901-20 PL.901-20 2022-12-26 30628429001227 AmnioTest (Nitrazine yellow swab 100 box) PL.901 PL.901 2022-12-26 10628429001742 Legionella DFA Mounting Medium PL.213 PL.213 2022-12-25 10628429001049 Prolex E. coli O157 Latex Test Reagent Kit (50 tests) PL.070B PL.070B 2022-12-26 10628429001056 Prolex E. coli O157 Latex Test Reagent Kit (100 tests) PL.071B PL.071B 2022-12-26 10628429001100 Prolex E. coli O157 Latex Reagent Control Negative PL.076B PL.076B 2022-12-26 10628429001124 Prolex E. coli Non-O157 Identification Kit PL.1070 PL.1070 2022-12-26 10628429001131 Prolex E. coli O26 Latex Reagent PL.1071 PL.1071 2022-12-26 10628429001148 Prolex E. coli O45 Latex Reagent PL.1072 PL.1072 2022-12-26 10628429001155 Prolex E. coli O103 Latex Reagent PL.1073 PL.1073 2022-12-26 10628429001162 Prolex E. coli O111 Latex Reagent PL.1074 PL.1074 2022-12-26 10628429001179 Prolex E. coli O121 Latex Reagent PL.1075 PL.1075 2022-12-26 10628429001186 Prolex E. coli O145 Latex Reagent PL.1076 PL.1076 2022-12-26 10628429001193 Prolex E. coli Non-O157 Negative Control Latex Reagent PL.1077 PL.1077 2022-12-26 10628429001209 Prolex E. coli O91 Latex Reagent PL.1078 PL.1078 2022-12-26 10628429001216 E. coli O157 Antiserum (3ml) PL.6250 PL.6250 2022-12-26 10628429001254 AmnioTest Colour Cards PL.902 PL.902 2022-12-26 10628429000080 Prolex Streptococcal Grouping Latex Kit PL.030 PL.030 2022-12-25 10628429000110 Prolex Streptococcal Grouping Reagent Latex Suspension Group A PL.031 PL.031 2022-12-25
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05032384013043 Latex Grouping Reagent A OXOID LIMITED GTZ 2024-06-19 05032384013050 Latex Grouping Reagent B OXOID LIMITED GTZ 2024-06-19 05032384013067 Latex Grouping Reagent C OXOID LIMITED GTZ 2024-06-19 05032384013074 Latex Grouping Reagent D OXOID LIMITED GTZ 2024-06-19 05032384013081 Latex Grouping Reagent F OXOID LIMITED GTZ 2024-06-19 05032384013098 Latex Grouping Reagent G OXOID LIMITED GTZ 2024-06-19 05032384519552 PathoDxtra Strep Grouping Kit (60 tests) OXOID LIMITED GTZ 2024-06-19 05032384519569 PathoDxtra Extraction Reagents OXOID LIMITED GTZ 2024-06-19 05032384519576 PATHODXTRA STREP GROUPING REAGENT SET OXOID LIMITED GTZ 2024-06-19 05032384519606 PATHODXTRA DISPOSABLE CARDS OXOID LIMITED GTZ 2024-06-19 05032384519835 PATHODXTRA STREP GROUP A LATEX OXOID LIMITED GTZ 2024-06-19 05032384519842 PATHODXTRA STREP GROUP B LATEX OXOID LIMITED GTZ 2024-06-19 05032384519859 PATHODXTRA STREP GROUP C LATEX OXOID LIMITED GTZ 2024-06-19 05032384519866 PATHODXTRA STREP GROUP D LATEX OXOID LIMITED GTZ 2024-06-19 05032384519873 PATHODXTRA STREP GROUP F LATEX OXOID LIMITED GTZ 2024-06-19 05032384519880 PATHODXTRA STREP GROUP G LATEX OXOID LIMITED GTZ 2024-06-19 05032384519897 PathoDxtra Polyvalent Positive Control OXOID LIMITED GTZ 2024-06-19 05032384012954 Oxoid Reaction Cards OXOID LIMITED GTZ 2024-06-18 05032384013036 Oxoid Streptococcal Grouping Kit OXOID LIMITED GTZ 2024-06-18 10628429000080 Prolex Streptococcal Grouping Latex Kit PRO-LAB, INCORPORATED GTZ 2022-12-25 10628429000110 Prolex Streptococcal Grouping Reagent Latex Suspension Group A PRO-LAB, INCORPORATED GTZ 2022-12-25 10628429000134 Prolex Streptococcal Grouping Reagent Latex Suspension Group B PRO-LAB, INCORPORATED GTZ 2022-12-25 10628429000158 Prolex Streptococcal Grouping Reagent Latex Suspension Group C PRO-LAB, INCORPORATED GTZ 2022-12-25 10628429000172 Prolex Streptococcal Grouping Reagent Latex Suspension Group D PRO-LAB, INCORPORATED GTZ 2022-12-25 10628429000196 Prolex Streptococcal Grouping Reagent Latex Suspension Group F PRO-LAB, INCORPORATED GTZ 2022-12-25 10628429000219 Prolex Streptococcal Grouping Reagent Latex Suspension Group G PRO-LAB, INCORPORATED GTZ 2022-12-25 10628429000233 Prolex Streptococcal Grouping Reagent Extraction Reagent 1 PRO-LAB, INCORPORATED GTZ 2022-12-25 10628429000240 Prolex Streptococcal Grouping Reagent Extraction Reagent 2 PRO-LAB, INCORPORATED GTZ 2022-12-25 10628429000257 Prolex Streptococcal Grouping Reagent Extraction Reagent 3 (2 x 8 ml) PRO-LAB, INCORPORATED GTZ 2022-12-25 10628429000295 Prolex Streptococcal- Select Grouping Latex Kit PRO-LAB, INCORPORATED GTZ 2022-12-25