Home GUDID 04250289504843 AESKULISA® DGP-Check
Primary DI 04250289504843
Brand AESKULISA® DGP-Check
Company Aesku.Diagnostics GmbH & Co. KG
Model 30-7515US
Catalog number 30-7515US
Device description AESKULISA® DGP-Check is an in-vitro diagnostic device. This solid phase enzyme immunoassay employs synthetic, deamidated gliadin-derived peptides for the combined semiquantitative and qualitative detection of IgA and IgG antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.
Published 2017-03-01
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 true 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 04250289504843 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04250289504843 04250289504843 4250289504843
GMDN Terms# Term, Definition table Term Definition Gliadin antibody IVD, kit, enzyme immunoassay (EIA) 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 an enzyme immunoassay (EIA) method. This test is intended to be used as an aid in the diagnosis of Coeliac disease.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 341714388 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true 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 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 00845714002960 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. MST 2016-10-27