TPLC - Total Product Life Cycle

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Device	instrumentation for clinical multiplex test systems
Regulation Description	Instrumentation for clinical multiplex test systems.
Definition	Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals from multiple probes or other ligands may be measured by fluorescence, luminescence, or other physical or chemical properties. The device may integrate scanning, reagent handling, hybridization, washing, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature for de
Product Code	NSU
Regulation Number	862.2570
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Negative Result	20	20
False Positive Result	4	4
No Apparent Adverse Event	3	3
Insufficient Device Problem Information	2	2
Contamination of Device Ingredient or Reagent	1	1
Overheating of Device	1	1
Failure to Seal	1	1
Sharp Edges	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Mechanical Problem	1	1
Fire	1	1
Data Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	30	30
No Clinical Signs, Symptoms or Conditions	27	27
Skin Tears	1	1
Exposure to Body Fluids	1	1