OLD
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Internal Polymerase Chain Reaction Control, Not Assay Specific
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Medical specialty
- Clinical Chemistry
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| REAL-TIME PCR INTERNAL CONTROL 2B SET (K083430) | Nanogen, Inc. | 2009-01-15 |
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