Home › Aesku.Diagnostics GmbH & Co. KG › AESKUSLIDES nDNA (Crithidia luciliae)

AESKUSLIDES nDNA (Crithidia luciliae)

Aesku.Diagnostics GmbH & Co. KG · Model 53.100.US · UDI-DI 04250289510394

LSW Prescription

510(k) clearances

Adverse events

Recalls

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. This in vitro diagnostic assay is used as an aid for the diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with other clinical and laboratory findings. The assay can be processed manually and analyzed at the microscope or processed and analyzed with HELIOS® Automated IFA System. All suggested results obtained with the HELIOS® Automated IFA System must be confirmed by trained personnel.

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).

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data 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.