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510(k) Data Aggregation
K Number
K172348Device Name
AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10
Manufacturer
Aesku Diagnostics GmbH & Co. KG
Date Cleared
2018-02-16
(197 days)
Product Code
LSW, ANT, PIV
Regulation Number
866.5100Why did this record match?
Applicant Name (Manufacturer) :
**Aesku Diagnostics GmbH **& Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay utilizing Crithidia luciliae coated slides as a substrate for the qualitative and/or semiquantitative determination of antibodies to native double stranded DNA (dsDNA) in human serum.
Each kit contains (Quantity depends on product variant):
- -Slides, each containing 10 wells coated with Crithidia Luciliae cells
- 4.0 ml vial containing Fluorescein (FITC) labelled Anti-human Antibody lgG conjugate in a solution of BSA, ready for use
- -0.5 ml vial of positive control containing human serum (diluted), ready for Use
- 0.5 ml vial of negative control containing diluted human serum, ready for use -
- -8.0 ml vial of mounting medium containing a solution of glycerol and PBS, ready for use
- 70 ml bottle of sample buffer, containing BSA, PBS and ready for use -
- -100 ml bottle of wash buffer, concentrated buffer 1:10 in distilled water, containing BSA, PBS.
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