FDA product code OUL: Thermocycler, Generic
OUL is the FDA product code for thermocycler, generic. It is a Class I device, regulated under 21 CFR 862.2310 and reviewed by the Clinical Chemistry panel. Devices under OUL reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Thermocycler, Generic |
| Device class | Class I |
| Regulation | 21 CFR 862.2310 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for OUL devices
openFDA lists no recalls for product code OUL.
Frequently asked questions
What is FDA product code OUL?
OUL is the FDA product code for thermocycler, generic. It is a Class I device, regulated under 21 CFR 862.2310 and reviewed by the Clinical Chemistry panel.
What device class is OUL?
Class I, regulation 21 CFR 862.2310. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OUL
- Run a recall and safety report across every OUL manufacturer
- Watch product code OUL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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