Home GUDID 07350049850269
Phadebact Monoclonal GC Test
Primary DI 07350049850269
Brand Phadebact Monoclonal GC Test
Company Mkl Diagnostics AB
Model 10-6419-12
Catalog number 10-6419-12
Published 2016-11-17
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Product Codes# Code, Name table Code Name LIC Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LIC Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07350049850269 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07350049850269 07350049850269 7350049850269
GMDN Terms# Term, Definition table Term Definition Neisseria gonorrhoeae 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 Neisseria gonorrhoeae bacteria, the causative agent of gonorrhoea, in a clinical specimen using an agglutination method.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 2 Degrees Celsius 8 Degrees Celsius Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 350472667 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company#