OLDClass I
Internal Polymerase Chain Reaction Control, Not Assay Specific
Clinical Chemistry · 21 CFR 862.1660
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.
MDR events0All time
Recalls0All time
Registered firms4Currently listed
510(k) clearances1All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
4 firms currently registered for this product code
510(k) clearances
1 clearances for this product code