DeviceClearance

Product code LSL— Microbiology

BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY

Classification name
Dna-Reagents, Neisseria
Device class
Class 2
Regulation
21 CFR 866.3390
Advisory panel
Microbiology
Total cleared
45
First cleared
Most recent

Market context for product code LSL

FDA has cleared 45 devices under product code LSL between 1987 and 2024, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code LSL

Recent clearances under product code LSL

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