Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis

NRL · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3045

Classification

FDA Product Code: NRL
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3045
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown