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AESKULISA® dsDNA G
Aesku.Diagnostics GmbH & Co. KG · Model 30-7142US · UDI-DI 04250289503440
LSW
Prescription
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. The assay is a tool in the diagnosis of systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings.
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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