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OULClass I

Thermocycler, Generic

Clinical Chemistry · 21 CFR 862.2310

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.

MDR events6All time
Recalls0All time
Registered firms7Currently listed
510(k) clearances0All time

Event type breakdown

Malfunction6

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510(k) clearances

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