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510(k) Data Aggregation
K Number
K203599Device Name
Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System
Manufacturer
Immuno Concepts N.A., Ltd.
Date Cleared
2023-05-26
(898 days)
Product Code
KTL
Regulation Number
866.5100Why did this record match?
Applicant Name (Manufacturer) :
Immuno Concepts N.A., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Immuno Concepts IgG Anti-nDNA Fluorescent Test System is for in vitro diagnostic use for the qualitative detection and semi-quantitation of anti-nDNA antibodies of the IgG class in human serum by manual fluorescent microscopy or with the Image Navigator® Fluorescence Semiautomated Microscope. The Immuno Concepts IgG Anti-IDNA Fluorescent Test System is to be used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with other clinical and laboratory findings. A trained operator must confirm results generated with the Image Navigator® semi-automated device and software.
Device Description
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