Home GUDID 10628429001056 Prolex E. coli O157 Latex Test Reagent Kit (100 tests)
Primary DI 10628429001056
Brand Prolex E. coli O157 Latex Test Reagent Kit (100 tests)
Company PRO-LAB, INCORPORATED
Model PL.071B
Catalog number PL.071B
Device description "ProlexTM E. coli O157 identifies Escherichia coli strains associated with Haemorrhagic Colitis and Haemolytic Uraemic Syndrome. Results can be obtained in two minutes from a single colony taken directly from selective agar. This unique reagent has been developed to remove common cross reactions with other similar ""O"" and ""H"" antigens, in particular E. hermanii. Available in 50 and 100 test formats, each kit has a maximum shelf life of two years from date of manufacture, and includes mixing sticks, agglutination cards, positive and negative controls."
Published 2022-12-26
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 GNA Antisera, All Types, Escherichia Coli
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GNA Antisera, All Types, Escherichia Coli Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10628429001056 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10628429001056 10628429001056
GMDN Terms# Term, Definition table Term Definition Escherichia coli antigen IVD, kit, agglutination A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Escherichia coli (E. coli) bacteria in a clinical specimen and/or culture isolate, using an agglutination method.
Regulatory Flags# DUNS number 960418395 Device count 1 Premarket exempt true Kit 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 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 10628429000134 Prolex Streptococcal Grouping Reagent Latex Suspension Group B PL.032 PL.032 2022-12-25
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10628429001049 Prolex E. coli O157 Latex Test Reagent Kit (50 tests) PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001100 Prolex E. coli O157 Latex Reagent Control Negative PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001124 Prolex E. coli Non-O157 Identification Kit PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001131 Prolex E. coli O26 Latex Reagent PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001148 Prolex E. coli O45 Latex Reagent PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001155 Prolex E. coli O103 Latex Reagent PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001162 Prolex E. coli O111 Latex Reagent PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001179 Prolex E. coli O121 Latex Reagent PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001186 Prolex E. coli O145 Latex Reagent PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001193 Prolex E. coli Non-O157 Negative Control Latex Reagent PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001209 Prolex E. coli O91 Latex Reagent PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001216 E. coli O157 Antiserum (3ml) PRO-LAB, INCORPORATED GNA 2022-12-26 00848838026768 REMEL REMEL, INC. GNA 2022-12-23 05032384028511 VET-RPLAKIT OXOID LIMITED GNA 2022-12-12 05032384013142 E. COLI O157 TEST KIT OXOID LIMITED GNA 2022-12-08 05032384034420 DRYSPOT E. COLI O157 OXOID LIMITED GNA 2022-12-04 05713106544013 E. coli H4 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544020 E. coli H5 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544044 E. coli H6 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544068 E. coli H7 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544075 E. coli H8 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544099 E. coli H9 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544105 E. coli H10 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544129 E. coli H11 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544143 E. coli H12 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544167 E. coli H14 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544174 E. coli H15 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544198 E. coli H16 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544211 E. coli H17 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544228 E. coli H18 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11