OUL

Thermocycler, Generic

Product code

OUL

Device name

Thermocycler, Generic

Device class

Class 1

21 CFR

21 CFR 862.2310

Medical specialty

Clinical Chemistry

Marketing pathway

510(K) Exempt

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).