DEVICE: AESKULISA® Scl-70 (04250289500531)
Device Identifier (DI) Information
AESKULISA® Scl-70
3111
In Commercial Distribution
Aesku.Diagnostics GmbH & Co. KG
3111
In Commercial Distribution
Aesku.Diagnostics GmbH & Co. KG
AESKULISA Scl-70 is a solid phase enzyme immunoassay with human recombinant 70 kDa fragment of DNA topoisomerase I for the quantitative and qualitative detection of antibodies against Scl-70 (70 kDa scleroderma antigen) in human serum. The assay is a tool in the differential diagnosis of systemic sclerosis.
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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55126 | Scleroderma-70 antibody (anti-Scl-70) 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 antibodies to scleroderma-70 (anti-Scl-70) in a clinical specimen, using an enzyme immunoassay (EIA) method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K032469 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
706a35c0-dd24-49ac-9967-0378e92b6add
July 06, 2018
3
September 27, 2016
July 06, 2018
3
September 27, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
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