DeviceClearance

Product code PIT— Microbiology

CL DETECT RAPID TEST

Classification name
Leishmania Spp. Antigen Detection Assay
Device class
Class 1
Regulation
21 CFR 866.3870
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“An in vitro diagnostic test for the detection of Leishmania spp. antigens to aid in the diagnosis of Leishmania spp. infection.”

— U.S. Food and Drug Administration, device classification record for product code PIT under 21 CFR 866.3870, via openFDA

Market context for product code PIT

FDA has cleared 1 device under product code PIT, 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 PIT

Recent clearances under product code PIT

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