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AESKULISA® dsDNA-G
Aesku.Diagnostics GmbH & Co. KG · Model 3142 · UDI-DI 04250289500647
1
510(k) clearances
5
Adverse events
1
Recalls
8
Facilities
Description
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).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-12-14 | Phadia US Inc | Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient test results). |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.