DeviceClearance

Product code OUZ— Microbiology

SMART LEISH, MODEL LGM1-050

Classification name
Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids
Device class
Class 1
Regulation
21 CFR 866.3870
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“Detection of Leishmania species in skin lesions.”

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

Market context for product code OUZ

FDA has cleared 1 device under product code OUZ, all in 2011, 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 OUZ

Recent clearances under product code OUZ

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