Home GUDID 00817273020396 Diamedix
Primary DI 00817273020396
Brand Diamedix
Company DIAMEDIX CORPORATION
Model 720-790
Device description """720-790 ANA ELISA Screen Test Kit"""
Published 2016-09-20
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 LKJ Antinuclear Antibody, Antigen, Control
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LKJ Antinuclear Antibody, Antigen, Control Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00817273020396 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 00817273020396 00817273020396 817273020396 0817273020396
GMDN Terms# Term, Definition table Term Definition Candida albicans immunoglobulin G (IgG) antibody IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the yeast Candida albicans 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 151765328 Device count 1 Kit true Lot or batch true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B3507207900 Gold Standard Diagnostics Is-ANA Screen ELISA Test Kit Gold Standard Diagnostics Corporation LKJ 2025-02-26 07333066015545 EliA Ro60 Well Phadia AB LKJ 2022-09-14 07333066015576 EliA Ro52 Well Phadia AB LKJ 2022-09-14 07333066014876 EliA Ro60 Well Phadia AB LKJ 2022-09-14 07333066014906 EliA Ro52 Well Phadia AB LKJ 2022-09-14 05391516747493 Immco CLARK LABORATORIES, INC. LKJ 2019-12-30 05391516746595 Immco Diagnostics CLARK LABORATORIES, INC. LKJ 2019-10-25 00845714003233 Immco Diagnostics IMMCO DIAGNOSTICS, INC. LKJ 2018-06-05 04250289503501 AESKULISA® ANA HEp-2 Aesku.Diagnostics GmbH & Co. KG LKJ 2017-02-28 00845714003219 Immco Diagnostics, Inc. IMMCO DIAGNOSTICS, INC. LKJ 2017-02-02 00845714004162 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-12-09 00845714004179 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-12-09 00845714003462 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-10-27 00845714004186 IMMCO DIAGNOSTIC IMMCO DIAGNOSTICS, INC. LKJ 2016-10-27 07333066014524 EliA U1RNP Well Phadia AB LKJ 2016-09-23 07333066014531 EliA Sm Well Phadia AB LKJ 2016-09-23 07333066014548 EliA Ro Well Phadia AB LKJ 2016-09-23 07333066014555 EliA La Well Phadia AB LKJ 2016-09-23 07333066014562 EliA CENP Well Phadia AB LKJ 2016-09-23 00840733101014 ANA Screen ELISA Test Kit MERIDIAN BIOSCIENCE, INC. LKJ 2016-09-23 07333066010564 EliA U1RNP Well Phadia AB LKJ 2016-09-23 07333066010571 EliA Sm Well Phadia AB LKJ 2016-09-23 07333066010588 EliA Ro Well Phadia AB LKJ 2016-09-23 07333066010595 EliA La Well Phadia AB LKJ 2016-09-23 07333066010601 EliA CENP Well Phadia AB LKJ 2016-09-23 00845714001932 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-23 00845714001949 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-23 00845714001956 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-23 00845714001963 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-23 00845714001970 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-23
erbadiagnostics.com