Home GUDID 00840733101014 ANA Screen ELISA Test Kit
Primary DI 00840733101014
Brand ANA Screen ELISA Test Kit
Company MERIDIAN BIOSCIENCE, INC.
Model 4884261
Catalog number 4884261
Device description The Antinuclear Antibody Screening Test is a qualitative enzyme immunassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain systemic rheumatic diseases. This assay collectively detects, in one well, total ANAs against double stranded DNA (dsDNA, nDNA) histones, SS-A/Ro, SS-B/La, Sm, SmRNP, Sci-70, Jo-1, and centrometric antigens, along with sera postive for immunoflourescent (IFA) HEp-2 ANAs.
Published 2016-09-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true 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 00840733101014 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 00840733101014 00840733101014 840733101014 0840733101014
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 092815364 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 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 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 00845714002182 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-23
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