FDA.reportPublic FDA data

AESKULISA® ASCA-A

Primary DI
04250289503143
Brand
AESKULISA® ASCA-A
Company
Aesku.Diagnostics GmbH & Co. KG
Model
7507US
Catalog number
7507US
Device description
AESKULISA ASCA-A is a solid phase enzyme immunoassay (ELISA) employing highly purified mannan for the quantitative and qualitative detection of IgA anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specifically mannan, a component of the outer cell wall of yeast. The assay is highly specific and sensitive for Crohn`s disease.
Published
2017-03-17
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
04250289503143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250289503143042502895031434250289503143

GMDN Terms#

Term, Definition table
TermDefinition
Saccharomyces cerevisiae immunoglobulin A (IgA) 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 A (IgA) 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
04250289500470AESKULISA® snRNP-C31052016-09-27
04250289500494AESKULISA® SS-A31072016-09-27
04250289500548AESKULISA® Cenp-B31122016-09-27
04250289500838AESKULISA® Cardiolipin-A32032016-09-27
04250289500852AESKULISA® ß2-Glyco-A32052016-09-27
04250289500951AESKULISA® ß2-Glyco-Check32152016-09-27
04250289501491AESKULISA® Glia-G35022016-09-27
04250289501521AESKULISA® ASCA-A35072016-09-27
04250289501538AESKULISA® ASCA-G35082016-09-27
04250289503051AESKULISA® Cardiolipin-A7203US7203US2017-02-28
04250289503624AESKULISA® DGP-A35132016-09-27
04250289500432AESKULISA® ANA-8Pro31012016-09-27
04250289500449AESKULISA® ENA-6S31022016-09-27
04250289500531AESKULISA® Scl-7031112016-09-27
04250289500555AESKULISA® Jo-131132016-09-27
04250289500579AESKULISA® ANA-HEp-231152016-09-27
04250289500647AESKULISA® dsDNA-G31422016-09-27
04250289502993AESKULISA® Scl-707111US7111US2017-02-28
04250289503679AESKULISA® DGP-Check35152016-09-27
04250289504843AESKULISA® DGP-Check30-7515US30-7515US2017-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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