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510(k) Data Aggregation
K Number
K051492Device Name
AESKULISA ASCA A
Manufacturer
AESKU.INC
Date Cleared
2005-11-14
(161 days)
Product Code
NBT
Regulation Number
866.5785Why did this record match?
Applicant Name (Manufacturer) :
AESKU.INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AESKULISA ASCA-A is a solid phase enzyme immunoassay (ELISA) employing purified mannan for the semi-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 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.
AESKULISA ASCA-G is a solid phase enzyme immunoassay (ELISA) employing purified mannan for the semi-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 an aid in the diagnosis of Crohn`s disease and should be used in conjunction with other serological tests and clinical findings.
Device Description
solid phase enzyme immunoassay (ELISA) employing purified mannan
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