FDA.reportPublic FDA data

AESKULISA® Glia-A

Primary DI
04250289502856
Brand
AESKULISA® Glia-A
Company
Aesku.Diagnostics GmbH & Co. KG
Model
30-7501US
Catalog number
30-7501US
Device description
AESKULISA Glia-A is a solid phase enzyme immunoassay employing highly purified alphaGliadin for the quantitative and qualitative detection of IgA antibodies against gliadin in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy). 30'+30'+30' automation incubation.
Published
2017-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MSTAntibodies, Gliadin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSTAntibodies, GliadinImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052439000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052439000AESKULISA GLIA A AND AESKULISA GLIA GAesku Diagnostics2006-02-07MST

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250289502856PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250289502856042502895028564250289502856

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with Coeliac disease in a clinical specimen, using an enzyme immunoassay (EIA) method. These antibodies may include autoimmune antibodies directed at gliadin (anti-gliadin IgA or IgG), endomysium (anti-endomysial antibodies), immunoglobulin A (anti-IgA) and/or tissue transglutaminase antibodies (anti-tTG).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341714388
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250289503440AESKULISA® dsDNA G30-7142US30-7142US2017-02-28
04250289503501AESKULISA® ANA HEp-2 30-7115US30-7115US2017-02-28
04250289504942AESKUSLIDES® ANA HEp-2-Gamma51.101.US.Bulk551.101.US.Bulk52025-05-27
04250289513487AESKUSLIDES® ANA-HEp-2 gamma 51.181.US51.181.US2025-04-06
04250289513562AESKUSLIDES® ANA-HEp-2 gamma 51.181.US.BULK551.181.US.BULK52025-04-06
04250289500005AESKUSLIDES® ANA-HEp-2 51.1002016-09-27
04250289500425AESKULISA® ANA-8Pro 31012016-09-27
04250289500449AESKULISA® ENA-6S 31022016-09-27
04250289500456AESKULISA® ENA-6Pro 31032016-09-27
04250289500579AESKULISA® ANA-HEp-2 31152016-09-27
04250289502917AESKULISA® ANA-8Pro 7101US7101US2017-02-28
04250289502924AESKULISA® ENA-6S 7102US7102US2017-02-28
04250289502931AESKULISA® ENA-6Pro 7103US7103US2017-02-28
04250289503020AESKULISA® ANA-HEp-2 7115US7115US2017-03-02
04250289504461AESKUSLIDES® ANA-HEp-2 51.100.US51.100.US2017-02-28
04250289504935AESKUSLIDES® ANA-HEp-2 gamma 51.101.US51.101.US2017-02-28
04250289510387AESKUSLIDES ANCA Formalin54.051.US2018-05-25
04250289510394AESKUSLIDES nDNA (Crithidia luciliae)53.100.US2018-05-14
04250289513531HELMED® Automated IFA ProcessorREF.HEL-1000.USREF.HEL-1000.US2025-01-03
04260186120008HELIOS® Automated IFA SystemREF.IOS-1000.USREF.IOS-1000.US2025-01-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474033700Gliadin IgA ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMST2023-08-29
04048474033717Gliadin IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMST2023-08-29
00840239033703Gliadin IgA ELISA DRG International IncMST2023-08-24
00840239033710Gliadin IgG ELISA DRG International IncMST2023-08-24
08430793040471Aptiva® Celiac Disease IgG ReagentINOVA DIAGNOSTICS, INC.MST2022-05-27
08430793040532Aptiva® Celiac Disease IgA ReagentINOVA DIAGNOSTICS, INC.MST2022-05-27
00894175000428AccuDiag ™Diagnostic Automation, Inc.MST2021-08-06
00847865013000BioPlex 2200BIO-RAD LABORATORIES, INC.MST2020-01-30
07333066019901ImmunoCAP Gliadin IgA/IgG Control LowPhadia ABMST2019-03-29
07333066019918ImmunoCAP Gliadin IgA Control HighPhadia ABMST2019-03-29
07333066019925ImmunoCAP Gliadin IgG Control HighPhadia ABMST2019-03-29
07333066000701ImmunoCAP Gliadin IgA/IgG Control LowPhadia ABMST2019-03-29
07333066000718ImmunoCAP Gliadin IgA Control HighPhadia ABMST2019-03-29
07333066000725ImmunoCAP Gliadin IgG Control HighPhadia ABMST2019-03-29
07333066019819ImmunoCAP Specific IgA/IgG Sample DiluentPhadia ABMST2019-03-28
07333066000732ImmunoCAP Specific IgA/IgG Sample DiluentPhadia ABMST2019-03-28
07333066019550ImmunoCAP Specific IgA CalibratorsPhadia ABMST2019-03-26
07333066019574ImmunoCAP Specific IgA Curve ControlsPhadia ABMST2019-03-26
00845714002663Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.MST2017-09-26
00845714002670Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.MST2017-09-26
04250289502863AESKULISA® Glia-G Aesku.Diagnostics GmbH & Co. KGMST2017-03-17
04250289503105AESKULISA® Glia-A Aesku.Diagnostics GmbH & Co. KGMST2017-03-17
04250289503112AESKULISA® Glia-G Aesku.Diagnostics GmbH & Co. KGMST2017-03-17
04250289504843AESKULISA® DGP-CheckAesku.Diagnostics GmbH & Co. KGMST2017-03-01
04250289504584AESKULISA® DGP-A Aesku.Diagnostics GmbH & Co. KGMST2017-02-28
04250289504591AESKULISA® DGP-G Aesku.Diagnostics GmbH & Co. KGMST2017-02-28
00845714002786IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MST2016-12-09
00845714002922IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MST2016-12-09
00845714004247IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MST2016-12-09
00845714002960IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MST2016-10-27