Product code LQH— Microbiology

BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY

Classification name
Dna-Reagents, Legionella
Device class
Class 2
Regulation
21 CFR 866.3300
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

Market context for product code LQH

FDA has cleared 2 devices under product code LQH between 1986 and 2004, filed by 2 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

Top applicants under product code LQH

Recent clearances under product code LQH

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