Home GUDID 00845714003223 IMMCO DIAGNOSTICS
Primary DI 00845714003223
Brand IMMCO DIAGNOSTICS
Company IMMCO DIAGNOSTICS, INC.
Model 2150-12
Catalog number 2150-12
Device description Hep-2 Cells Slide
Published 2016-09-23
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false 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 00845714003223 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 00845714003223 00845714003223 845714003223 0845714003223
GMDN Terms# Term, Definition table Term Definition Multiple antinuclear antibody (ANA) screening IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen.
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 Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 079935300 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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
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