DeviceClearance

Product code NRL— Microbiology

QUICKELISA ANTHRAX-PA KIT

Classification name
Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis
Device class
Class 2
Regulation
21 CFR 866.3045
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“The elisa assay for antibodies to b. Anthracis is used to detect an immunological response to proteins secreted by b. Anthracis; As an aid in the laboratory diagnosis of anthrax.”

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

Market context for product code NRL

FDA has cleared 1 device under product code NRL, all in 2004, 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 NRL

Recent clearances under product code NRL

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