Internal Polymerase Chain Reaction Control, Not Assay Specific
OLD · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1660
Classification
FDA Product Code
OLD
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 862.1660
Review panel
CH
Medical specialty
Clinical Chemistry
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.