# Thermocycler, Generic
> **Product code: OUL** · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.2310
## Classification
- **FDA Product Code:** OUL
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 862.2310
- **Review panel:** CH
- **Medical specialty:** Clinical Chemistry
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 7
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OUL)
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