DeviceClearance

Product code OLD— Clinical Chemistry

REAL-TIME PCR INTERNAL CONTROL 2B SET

Classification name
Internal Polymerase Chain Reaction Control, Not Assay Specific
Device class
Class 1
Regulation
21 CFR 862.1660
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OLD under 21 CFR 862.1660, via openFDA

Market context for product code OLD

FDA has cleared 1 device under product code OLD, all in 2009, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code OLD

Recent clearances under product code OLD

Data sourced from openFDA. This site is unofficial and independent of the FDA.