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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device thermocycler, generic
Regulation Description Clinical sample concentrator.
Definition A thermocycler is an automated laboratory apparatus intended to amplify specific segments of double stranded nucleic acids isolated from a clinical sample via the polymerase chain reaction process. The nucleic acid sequences are amplified in the presence of specific primers, buffers, and thermostable polymerases, by raising and lowering the thermal block temperature at specific rates using pre-programmed steps, based on the specifications of the test which is being run. It may integrate interchangeable blocks of different materials or to accommodate different well and tube formats.
Product CodeOUL
Regulation Number 862.2310
Device Class 1

Device Problems
Device operates differently than expected 2
Device displays error message 1
Total Device Problems 3