Home GUDID 10628429001186 Prolex E. coli O145 Latex Reagent
Primary DI 10628429001186
Brand Prolex E. coli O145 Latex Reagent
Company PRO-LAB, INCORPORATED
Model PL.1076
Catalog number PL.1076
Device description Prolex E. coli O145 Latex Reagent
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 10628429001186 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10628429001186 10628429001186
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 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 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 10628429001056 Prolex E. coli O157 Latex Test Reagent Kit (100 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 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