Home GUDID 10628429001889 Legionella pneumophila Serogroup 10 DFA Reagent
Primary DI 10628429001889
Brand Legionella pneumophila Serogroup 10 DFA Reagent
Company PRO-LAB, INCORPORATED
Model PL.279
Catalog number PL.279
Device description The Direct Fluorescent Antibody Reagents are intended for the presumptive (serological) identification of Legionella pneumophila serogroups 2 through 14 from culture isolates.
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 LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10628429001889 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10628429001889 10628429001889
GMDN Terms# Term, Definition table Term Definition Legionella pneumophila nucleic acid IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nucleic acid from one or multiple serogroups of Legionella pneumophila bacteria in a clinical specimen.
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
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