Home GUDID 08028169204055 a-Gliatest IgA
Primary DI 08028169204055
Brand a-Gliatest IgA
Company EUROSPITAL SPA
Model 9167
Device description 1. Antibody coated plate: 12-1 x 8 wells.2. Enzyme conjugate antibody (IgA):1x15mL vial.3. Calibrators: 5 vials containing 1.5 ml human positive serum at five concentrations (0, 10, 20, 50 and 100 AU/ml).4. Control 1: 1x1.5 mL vial.5. Control 2: 1x1.5 mL vial.6. Sample Diluent (10x): 1 x20mL vial.7. Substrate: 1 x15 ml vial.8. Wash solution (20x): 1x50 mL vial.9. Stop Solution: 1 x15 ml vial.
Published 2016-07-04
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 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 08028169204055 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08028169204055 08028169204055 8028169204055
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 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 429447667 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 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
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