DEVICE: AESKULISA® dsDNA-G (04250289500647)

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Device Identifier (DI) Information

AESKULISA® dsDNA-G
3142

Aesku.Diagnostics GmbH & Co. KG
04250289500647
GS1
1
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).
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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

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Product Code Product Code Name
LSW Anti-Dna Antibody, Antigen And Control
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 27, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Unit of Use DI

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Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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