Home GUDID 04099466112248 Pancreatic Elastase ELISA
Primary DI 04099466112248
Brand Pancreatic Elastase ELISA
Company Seramun Diagnostica GmbH
Model G09040
Published 2024-11-21
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 JNO N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JNO N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04099466112248 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04099466112248 04099466112248 4099466112248
GMDN Terms# Term, Definition table Term Definition Pancreatic elastase (PE) IVD, kit, enzyme immunoassay (EIA) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of pancreatic elastase (PE) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of conditions associated with pancreatic insufficiency (e.g., chronic pancreatitis).
Regulatory Flags# DUNS number 344006309 Device count 1 Premarket exempt true Kit 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 04099466400116 Stool Preparation Set ACS-001 2024-11-21 04099466112231 Pancreatic Elastase ELISA G09038USA 2023-10-01
Other Devices Sharing Product Codes#