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AESKUSLIDES® nDNA (Crithidia luciliae)
Aesku.Diagnostics GmbH & Co. KG · Model 53.120.US · UDI-DI 04250289513401
LSW
Prescription
1
510(k) clearances
5
Adverse events
1
Recalls
8
Facilities
Description
AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay utilizing Crithidia luciliae coated slides as a substrate for the qualitative and/or semi-quantitative determination of antibodies to native double stranded DNA (dsDNA) in human serum.
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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