DeviceClearance

Product code NVQ— Microbiology

GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC

Classification name
Bacteriophage And Controls, B. Anthracis Lysis
Device class
Class 2
Regulation
21 CFR 866.3045
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

FDA classification definition

“A gamma phage lysis assay intended for the identification of bacillus anthracis from non-hemolytic, aerobic gram positive colonies isolated from sheep blood agar. To aid in the laboratory identification of bacillus anthracis culture growth by lysis with a specific bacteriophage.”

— U.S. Food and Drug Administration, device classification record for product code NVQ under 21 CFR 866.3045, via openFDA

Market context for product code NVQ

FDA has cleared 2 devices under product code NVQ between 2005 and 2015, 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 NVQ

Recent clearances under product code NVQ

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