NRL

Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis

Product code

NRL

Device name

Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis

Device class

Class 2

21 CFR

21 CFR 866.3045

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).