FDA.reportPublic FDA data

AESKULISA® ASCA-G

Primary DI
04250289501538
Brand
AESKULISA® ASCA-G
Company
Aesku.Diagnostics GmbH & Co. KG
Model
3508
Device description
AESKULISA ASCA-G is a solid phase enzyme immunoassay (ELISA) employing highly purified mannan for the quantitative and qualitative detection of IgG anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specific mannan, a component of the outer cell wall of yeast. The assay is highly specific and sensitive for Crohn`s disease.
Published
2016-09-27
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
NBTAntibodies,Saccharomyces Cerevisiae (S.Cerevisiae)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBTAntibodies, Saccharomyces Cerevisiae (S.Cerevisiae)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051492000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051492000AESKULISA ASCA AAesku, Inc.2005-11-14NBT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250289501538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250289501538042502895015384250289501538

GMDN Terms#

Term, Definition table
TermDefinition
Saccharomyces cerevisiae immunoglobulin G (IgG) 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 immunoglobulin G (IgG) antibodies to the yeast Saccharomyces cerevisiae in a clinical specimen, using an enzyme immunoassay (EIA) method.

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
Kit
true
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
04250289503143AESKULISA® ASCA-A Aesku.Diagnostics GmbH & Co. KGNBT2017-03-17
04250289503150AESKULISA® ASCA-G Aesku.Diagnostics GmbH & Co. KGNBT2017-03-17
04250289502894AESKULISA® ASCA-A Aesku.Diagnostics GmbH & Co. KGNBT2017-02-28
04250289502900AESKULISA® ASCA-G Aesku.Diagnostics GmbH & Co. KGNBT2017-02-28
04250289501521AESKULISA® ASCA-A Aesku.Diagnostics GmbH & Co. KGNBT2016-09-27
00847817018534Autoimmune EIABIO-RAD LABORATORIES, INC.NBT2016-09-12
00847817018541Autoimmune EIABIO-RAD LABORATORIES, INC.NBT2016-09-12
08426950514206QUANTA Lite® ASCA IgG ELISAINOVA DIAGNOSTICS, INC.NBT2016-08-31
08426950514213QUANTA Lite® ASCA IgA ELISAINOVA DIAGNOSTICS, INC.NBT2016-08-31
00857031002325ASCA-CHEKTECHLAB, INC.NBT2016-08-20