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FDA product code NRL

Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis

MicrobiologyClass 221 CFR 866.3045
US regulatory classifications
US Product Code (FDA)
NRL
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.3045
Medical specialty
Microbiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.