OLD

Internal Polymerase Chain Reaction Control, Not Assay Specific

Product code

OLD

Device name

Internal Polymerase Chain Reaction Control, Not Assay Specific

Device class

Class 1

21 CFR

21 CFR 862.1660

Medical specialty

Clinical Chemistry

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).