Home GUDID 06438147009343 AutoDELFIA hCG kit
Primary DI 06438147009343
Brand AutoDELFIA hCG kit
Company Wallac Oy
Model B007-112
Catalog number B007-112
Device description Time-resolved fluoroimmunoassay for the quantitative determination of human chorionic gonadotropin (hCG).
Published 2016-02-11
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name JHJ Agglutination Method, Human Chorionic Gonadotropin
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JHJ Agglutination Method, Human Chorionic Gonadotropin Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 06438147009343 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06438147009343 06438147009343 6438147009343
GMDN Terms# Term, Definition table Term Definition Total human chorionic gonadotropin (HCG) IVD, kit, fluorescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which may include intact HCG, nicked HCG, free alpha-HCG subunits and/or free beta-HCG subunits, in a clinical specimen using a fluorescent immunoassay method.
Regulatory Flags# DUNS number 540156544 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 10722355001446 Detector Cept-D Polyclonal Immunostics Company, Inc JHJ 2016-09-20 06438147009176 DELFIA hCG kit Wallac Oy JHJ 2016-02-11 06438147009336 AutoDELFIA hCG kit Wallac Oy JHJ 2016-02-11