Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis
The ELISA Assay for Antibodies to Bacillus anthracis is a microbiology diagnostic device used to detect an immunological response to proteins secreted by B. anthracis, serving as an aid in the laboratory diagnosis of anthrax. Enzyme-linked immunosorbent assay (ELISA) technology is used to identify antibodies indicative of anthrax exposure or infection. This is an FDA Class 2 device regulated under 21 CFR 866.3045 in the Microbiology specialty, with product code NRL, requiring 510(k) clearance. It is not an implant and does not provide life-sustaining support.
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Basic Information
- Product Code
- NRL
- Device Class
- FDA class 2
- Regulation Number
- 866.3045
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K040407 | QUICKELISA ANTHRAX-PA KIT | Jun 03, 2004 | Substantially Equivalent | Immunetics, Inc. |