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OULClass I

Thermocycler, Generic

21 CFR 862.2310 / Clinical Chemistry
FDA source (opens on fda.gov)

OUL is the FDA product code for Thermocycler, Generic, a class I device type, regulated under 21 CFR 862.2310. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OUL
Device name
Thermocycler, Generic
FDA 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.
Regulation
21 CFR 862.2310
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code