DeviceClearance

Product code NWZ— Microbiology

SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF

Classification name
Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids
Device class
Class 2
Regulation
21 CFR 866.3045
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“Aid in the identification of Bacillus Anthracis”

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

Market context for product code NWZ

FDA has cleared 1 device under product code NWZ, all in 2006, filed by 1 applicant company. 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.

Top applicants under product code NWZ

Recent clearances under product code NWZ

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