DEVICE: AESKULISA® dsDNA-G (04250289500647)
Device Identifier (DI) Information
AESKULISA® dsDNA-G
3142
In Commercial Distribution
Aesku.Diagnostics GmbH & Co. KG
3142
In Commercial Distribution
Aesku.Diagnostics GmbH & Co. KG
AESKULISA dsDNA-G is a solid phase enzyme immunoassay with human recombinant double-stranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum. Anti-dsDNA antibodies mainly recognize the phosphat units of the DNA, thus these autoantibodies also bind single stranded DNA (ssDNA). To ensure correct quantitation of anti-dsDNA antibodies the used antigen has been proven to be free of contamination with ssDNA. The assay is a tool in the differential diagnosis of systemic lupus erythematosus (SLE).
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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54902 | Double stranded DNA antibody (anti-dsDNA) 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 double stranded DNA (anti-dsDNA) 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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LSW | Anti-Dna Antibody, Antigen And Control |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K041628 | 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
40511a2d-fc0d-4b0e-b1ea-9c5ece4ab3d5
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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Unit of Use DI
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Unit of Use DI Number:
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Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined