Product code OUL

Device name
Thermocycler, Generic
Medical specialty
Clinical Chemistry
Device class
1
Regulation number
862.2310
Review panel
CH
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.
Source
FDA openFDA device classification dataset