DeviceClearance

Product code NPO— Microbiology

REDLINE ANTHRAX ALERT TEST

Classification name
Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody
Device class
Class 2
Regulation
21 CFR 866.3045
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“A serological reagent to distinguish b. Anthracis culture growth from other bacillus spp. Growth”

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

Market context for product code NPO

FDA has cleared 1 device under product code NPO, all in 2003, 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 NPO

Recent clearances under product code NPO

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