Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Example #3.

Antibodies to islet cells

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Immunofluorescent antibody (IFA) test to detect the presence of antibodies to islet cells in human serum.

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Example #4.

Diagnostic Instrument

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A real-time qualitative PCR assay for the detection of 7 somatic mutations in codons 12 and 13 of the human KRAS oncogene using the diagnostic instrument. The kit is intended for use with DNA extracted from formalin-fixed paraffin-embedded (FFPE) samples of colorectal cancer (CRC) or non-small cell lung cancer (NSCLC) samples acquired by resection, core needle biopsy (CNB) or fine needle aspiration (FNA).

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