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NRL

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3045
Medical specialty
Microbiology
FDA 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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RecordFirmDate
QUICKELISA ANTHRAX-PA KIT (K040407)Immunetics, Inc.2004-06-03

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