Home GUDID 10628429001810 Prolex Legionella micdadei
Primary DI 10628429001810
Brand Prolex Legionella micdadei
Company PRO-LAB, INCORPORATED
Model PL.221
Catalog number PL.221
Device description Each dropper bottle contains 2.7 ml of latex reagent for the detection of Legionella micdadei from culture plates.
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 10628429001810 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10628429001810 10628429001810
GMDN Terms# Term, Definition table Term Definition Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to multiple species of Legionella bacteria in a clinical specimen, using a fluorescent immunoassay method. Legionella species intended to be detected may include Legionella pneumophila, L. longbeachae, L. jordanis, L. bozemanii, L. gormanii, L. micdadei, and L. dumoffii which are associated with pneumonia-like respiratory infection and Legionnaires' disease.
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 10628429001674 Legionella pneumophila Serogroup 2 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001681 Legionella pneumophila Serogroup 3 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001698 Legionella pneumophila Serogroup 4 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001704 Legionella pneumophila Serogroup 5 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001711 Legionella pneumophila Serogroup 6 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001728 Legionella micdadei DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001735 Phosphate Buffered Saline (pH 7.6) PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001759 Legionella DFA Negative Control PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001766 Prolex Legionella pneumophila Serogroup 2 Latex Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001773 Prolex Legionella pneumophila Serogroup 3 Latex Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001780 Prolex Legionella pneumophila Serogroup 4 Latex Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001797 Prolex Legionella pneumophila Serogroup 5 Latex Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001803 Prolex Legionella pneumophila Serogroup 6 Latex Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001827 Prolex Legionella pneumophila Negative Control Latex Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001834 Legionella pneumophila Serogroup 1 DFA Kit (50 tests) PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001841 Legionella pneumophila Serogroups 1-14 DFA Kit (50 tests) PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001858 Legionella pneumophila Serogroup 7 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001865 Legionella pneumophila Serogroup 8 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001872 Legionella pneumophila Serogroup 9 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001889 Legionella pneumophila Serogroup 10 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001896 Legionella pneumophila Serogroup 11 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001902 Legionella pneumophila Serogroup 12 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001919 Legionella pneumophila Serogroup 13 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001926 Legionella pneumophila Serogroup 14 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001933 Legionella pneumophila Positive Control Serogroups 1-14 PRO-LAB, INCORPORATED LHL 2022-12-25 10628429002015 Prolex Legionella pneumophila Serogroup 7 Latex Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429002022 Prolex Legionella pneumophila Serogroup 8 Latex Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429002039 Prolex Legionella pneumophila Serogroup 9 Latex Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429002046 Prolex Legionella pneumophila Serogroup 10 Latex Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429002053 Prolex Legionella pneumophila Serogroup 11 Latex Reagent PRO-LAB, INCORPORATED LHL 2022-12-25