FDA.reportPublic FDA data

AESKULISA® ASCA-A

Primary DI
04250289502894
Brand
AESKULISA® ASCA-A
Company
Aesku.Diagnostics GmbH & Co. KG
Model
30-7507US
Catalog number
30-7507US
Device description
AESKULISA® ASCA-A is a solid phase enzyme immunoassay (ELISA) employing purified mannan for the semiquantitative 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 AESKULISA® ASCA-A kit should not be used as a screening test for ASCA, since some Crohn’s disease patients do not have ASCA IgA antibodies. The AESKULISA® ASCA-A kit should be used to compliment, but not to replace or to substitute for ASCA IgG antibody testing. The assay is an aid in the diagnosis of Crohn’s disease and should be used in conjunction with other serological tests and clinical findings.
Published
2017-02-28
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
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
04250289502894PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250289502894042502895028944250289502894

GMDN Terms#

Term, Definition table
TermDefinition
Saccharomyces cerevisiae immunoglobulin A (IgA)/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 A (IgA) and 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 Temperature00

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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250289502849AESKULISA® ß2-Glyco-Check30-7215US30-7215US2017-02-28
04250289502979AESKULISA® SS-A7107US7107US2017-02-28
04250289503006AESKULISA® Cenp-B7112US7112US2017-02-28
04250289504584AESKULISA® DGP-A30-7513US30-7513US2017-02-28
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

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
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