Home GUDID 07333066010731
EliA Gliadin IgG Well
Primary DI 07333066010731
Brand EliA Gliadin IgG Well
Company Phadia AB
Model DECC055200
Catalog number DECC055200
Device description EliA Gliadin IgG Well
Published 2016-09-23
Public version status Update
Distribution status 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 MST Antibodies, gliadin
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MST Antibodies, Gliadin Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07333066010731 Package GS1 4 In Commercial Distribution 07333066014692 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07333066010731 07333066010731 7333066010731 07333066014692 07333066014692 7333066014692
GMDN Terms# Term, Definition table Term Definition Gliadin antibody IVD, kit, fluorescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-gliadin antibodies in a clinical specimen, using a fluorescent immunoassay method.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 354019424 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 false 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 04048474033700 Gliadin IgA ELISA DRG Instruments Gesellschaft mit beschränkter Haftung MST 2023-08-29 04048474033717 Gliadin IgG ELISA DRG Instruments Gesellschaft mit beschränkter Haftung MST 2023-08-29 00840239033703 Gliadin IgA ELISA DRG International Inc MST 2023-08-24 00840239033710 Gliadin IgG ELISA DRG International Inc MST 2023-08-24 08430793040471 Aptiva® Celiac Disease IgG Reagent INOVA DIAGNOSTICS, INC. MST 2022-05-27 08430793040532 Aptiva® Celiac Disease IgA Reagent INOVA DIAGNOSTICS, INC. MST 2022-05-27 00894175000428 AccuDiag ™ Diagnostic Automation, Inc. MST 2021-08-06 00847865013000 BioPlex 2200 BIO-RAD LABORATORIES, INC. MST 2020-01-30 07333066019901 ImmunoCAP Gliadin IgA/IgG Control Low Phadia AB MST 2019-03-29 07333066019918 ImmunoCAP Gliadin IgA Control High Phadia AB MST 2019-03-29 07333066019925 ImmunoCAP Gliadin IgG Control High Phadia AB MST 2019-03-29 07333066000701 ImmunoCAP Gliadin IgA/IgG Control Low Phadia AB MST 2019-03-29 07333066000718 ImmunoCAP Gliadin IgA Control High Phadia AB MST 2019-03-29 07333066000725 ImmunoCAP Gliadin IgG Control High Phadia AB MST 2019-03-29 07333066019819 ImmunoCAP Specific IgA/IgG Sample Diluent Phadia AB MST 2019-03-28 07333066000732 ImmunoCAP Specific IgA/IgG Sample Diluent Phadia AB MST 2019-03-28 07333066019550 ImmunoCAP Specific IgA Calibrators Phadia AB MST 2019-03-26 07333066019574 ImmunoCAP Specific IgA Curve Controls Phadia AB MST 2019-03-26 00845714002663 Immco Diagnostics, Inc. IMMCO DIAGNOSTICS, INC. MST 2017-09-26 00845714002670 Immco Diagnostics, Inc. IMMCO DIAGNOSTICS, INC. MST 2017-09-26 04250289502863 AESKULISA® Glia-G Aesku.Diagnostics GmbH & Co. KG MST 2017-03-17 04250289503105 AESKULISA® Glia-A Aesku.Diagnostics GmbH & Co. KG MST 2017-03-17 04250289503112 AESKULISA® Glia-G Aesku.Diagnostics GmbH & Co. KG MST 2017-03-17 04250289504843 AESKULISA® DGP-Check Aesku.Diagnostics GmbH & Co. KG MST 2017-03-01 04250289502856 AESKULISA® Glia-A Aesku.Diagnostics GmbH & Co. KG MST 2017-02-28 04250289504584 AESKULISA® DGP-A Aesku.Diagnostics GmbH & Co. KG MST 2017-02-28 04250289504591 AESKULISA® DGP-G Aesku.Diagnostics GmbH & Co. KG MST 2017-02-28 00845714002786 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. MST 2016-12-09 00845714002922 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. MST 2016-12-09 00845714004247 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. MST 2016-12-09