OLD — Internal Polymerase Chain Reaction Control, Not Assay Specific Class I
FDA product code OLD covers "Internal Polymerase Chain Reaction Control, Not Assay Specific", a Class I medical device regulated under 21 CFR 862.1660. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OLD
- Device Class
- Class I
- Regulation Number
- 862.1660
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
Internal control that can be used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K083430 | nanogen | REAL-TIME PCR INTERNAL CONTROL 2B SET | January 15, 2009 |