OUL — Thermocycler, Generic Class I
FDA product code OUL covers "Thermocycler, Generic", a Class I medical device regulated under 21 CFR 862.2310. Submissions are reviewed by the Clinical Chemistry panel.
Classification Details
- Product Code
- OUL
- Device Class
- Class I
- Regulation Number
- 862.2310
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.