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 Pres
| Device Type ID | 648 |
| Device Name | Thermocycler, Generic |
| Physical State | Should Not Include Real-time Thermocyclers Or Instruments With Analyzers For Fluorescence, Other Measuring Techniques, Or Detection Methods Or Integrate Sample And/or Reagent Handling. |
| Technical Method | A Thermocycler Is Intended Amplify Specific Sequences Of Double Stranded Nucleic Acids Using The Polymerase Chain Process. The Device Includes A Thermal Block With Holes Designed To Accommodate The Insertion Of Special Tubes Or Plates Holding The Ass |
| Target Area | Not Applicable |
| Regulation Description | Clinical Sample Concentrator. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.2310 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OUL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 648 |
| Device | Thermocycler, Generic |
| Product Code | OUL |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Clinical Sample Concentrator. |
| CFR Regulation Number | 862.2310 [🔎] |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 2 |
Device Displays Incorrect Message | 1 |
| Total Device Problems | 3 |