Home GUDID 00816576023127 NA
Primary DI 00816576023127
Brand NA
Company HARDY DIAGNOSTICS
Model 294746
Catalog number 294746
Device description Legionella pneumophilia As Gp. 1, 2ml
Published 2017-06-08
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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 00816576023127 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00816576023127 00816576023127 816576023127 0816576023127
GMDN Terms# Term, Definition table Term Definition Legionella pneumophila antigen 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 antigens from one or multiple serogroups of Legionella pneumophila bacteria in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 039981550 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Contains natural rubber latex true Other Devices From This Company# 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 10628429001810 Prolex Legionella micdadei 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
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