Thermocycler, Generic
The Thermocycler, Generic (product code OUL) is an automated laboratory apparatus intended to amplify specific segments of double-stranded nucleic acids from clinical samples via the polymerase chain reaction (PCR) process. It raises and lowers a thermal block through pre-programmed temperature steps in the presence of specific primers, buffers, and thermostable polymerases, and may accommodate interchangeable blocks for different tube formats. As an FDA Class 1 device under regulation 862.2310, it is subject only to general controls and falls within the Clinical Chemistry specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OUL
- Device Class
- FDA class 1
- Regulation Number
- 862.2310
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.