Home GUDID 07350108630078 Diabetes Antigen Control (Unassayed)
Primary DI 07350108630078
Brand Diabetes Antigen Control (Unassayed)
Company Mercodia AB
Model 10-1134-01
Catalog number 10-1134-01
Device description Mercodia Diabetes Antigen Control is designed to be used as a two-level control for human insulin, C-peptide and proinsulin. It is manufactured from human serum and human insulin, C-peptide and proinsulin.
Published 2020-04-08
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name OHQ Multi-Analyte Controls Unassayed
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OHQ Multi-Analyte Controls Unassayed Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07350108630078 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07350108630078 07350108630078 7350108630078
GMDN Terms# Term, Definition table Term Definition Insulin IVD, control A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of insulin 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 354553091 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 07350108630047 Insulin ELISA Kit (DAKO) K2379 K2379 2020-04-08 07350108630108 Mercodia Oxidized LDL ELISA 10-1143-01 10-1143-01 2020-04-08 07350108630115 Mercodia Glucagon ELISA 10-1271-01 10-1271-01 2020-04-08 07350108630139 Mercodia Oxidized LDL ELISA 10-1143-01 10-1143-01 2021-09-01 07350108630122 Mercodia Glucagon ELISA 10-1271-01 10-1271-01 2020-10-01 07350108630016 Mercodia Lp(a) ELISA 10-1106-01 10-1106-01 2020-04-08 07350108630023 Mercodia Insulin ELISA 10-1113-01 10-1113-01 2020-04-08 07350108630030 Mercodia Insulin ELISA 10 pack 10-1113-10 10-1113-10 2020-04-08 07350108630054 Mercodia Iso-Insulin ELISA 10-1128-01 10-1128-01 2020-04-08 07350108630061 Mercodia Ultrasensitive Insulin ELISA 10-1132-01 10-1132-01 2020-04-08 07350108630085 Mercodia C-peptide ELISA 10-1136-01 10-1136-01 2020-04-08 07350108630092 Mercodia Ultrasensitive C-peptide ELISA 10-1141-01 10-1141-01 2020-04-08
Other Devices Sharing Product Codes# 
mercodia.com