Product code NRL

Device name
Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis
Medical specialty
Microbiology
Device class
2
Regulation number
866.3045
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.
Source
FDA openFDA device classification dataset