DEVICE: AESKULISA® ASCA-A (04250289501521)
Device Identifier (DI) Information
AESKULISA® ASCA-A
3507
In Commercial Distribution
Aesku.Diagnostics GmbH & Co. KG
3507
In Commercial Distribution
Aesku.Diagnostics GmbH & Co. KG
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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52100 | 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.
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FDA Product Code
[?]Product Code | Product Code Name |
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NBT | Antibodies,Saccharomyces Cerevisiae (S.Cerevisiae) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K051492 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
181cef84-d96f-41aa-84ba-1550b94e9168
July 06, 2018
3
September 27, 2016
July 06, 2018
3
September 27, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined