Home GUDID 17350066140326 HE4 EIA
Primary DI 17350066140326
Brand HE4 EIA
Company Fujirebio Diagnostics AB
Model 404-10US
Published 2016-09-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name OIU Test, Epithelial Ovarian Tumor Associated Antigen (He4)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OIU Test, Epithelial Ovarian Tumor Associated Antigen (He4) Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 17350066140326 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 17350066140326 17350066140326
GMDN Terms# Term, Definition table Term Definition Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of human epididymis protein 4 (HE4) ovarian cancer marker in a clinical specimen, using a chemiluminescent immunoassay method.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 20 Degrees Celsius 25 Degrees Celsius Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 357159631 Device count 1 Kit true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# 
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