DeviceClearance

Product code PCL— Microbiology

CAPTIA MEASLES IGM

Classification name
Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
Device class
Class 1
Regulation
21 CFR 866.3520
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“The qualitative detection of measles specific IgM antibodies in serum or plasma.”

— U.S. Food and Drug Administration, device classification record for product code PCL under 21 CFR 866.3520, via openFDA

Market context for product code PCL

FDA has cleared 1 device under product code PCL, all in 2014, 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 PCL

Recent clearances under product code PCL

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