Home GUDID 00817089021433 Diazyme
Primary DI 00817089021433
Brand Diazyme
Company DIAZYME LABORATORIES, INC.
Model 10-0148
Published 2020-07-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2 Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00817089021433 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 00817089021433 00817089021433 817089021433 0817089021433
GMDN Terms# Term, Definition table Term Definition Phospholipase A2 IVD, kit, enzyme spectrophotometry A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the enzyme phospholipase A2 in a clinical specimen, using an enzyme spectrophotometry method. It is used as an aid in the diagnosis and risk assessment of atherosclerotic diseases such as coronary artery disease and ischemic stroke.
Regulatory Flags# DUNS number 080507219 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00817089023222 Diazyme DIAZYME LABORATORIES, INC. NOE 2026-01-21 00817089023239 Diazyme DIAZYME LABORATORIES, INC. NOE 2026-01-21