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TPLC - Total Product Life Cycle

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Device dna genetic analyzer
Regulation Description Instrumentation for clinical multiplex test systems.
Definition A genetic analyzer is an automated clinical multiplex instrument system intended to measure and sort signals generated by multiple fluorescent dyes in order to analyze DNA/RNA molecules in an assay from a clinical sample. Individual nucleotide sequences and DNA fragment sizes are identified using chain- or dye-termination or dye primer cycle sequencing, or PCR amplification with labeled primers, respectively. Labeled nucleotides and DNA fragments are separated by size and charge using a polymer-based separation matrix with capillary electrophoresis or other method. Fluorescence emissions are measured using filters on a photodiode or other detector and interpreted with software.
Product CodePCA
Regulation Number 862.2570
Device Class 2

Device Problems
Failure to calibrate 1
Device operates differently than expected 1
Total Device Problems 2