QID · Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
Microbiology · 21 CFR 866.4002 · Class 2
Overview
| Product Code | QID |
|---|---|
| Device Name | Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens |
| Regulation | 21 CFR 866.4002 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| Life-Sustaining | Yes |
Identification
A device to detect antigens of biothreat microbial agents in human clinical specimens is identified as an in vitro diagnostic device intended for the detection of antigens of microbial agents in specimens collected from patients with signs and symptoms of infection with biothreat microbial agents and who have been exposed to these agents or are suspected or at risk of exposure. Devices to detect antigens of biothreat microbial agents in human clinical specimens may be used for cadaver testing if the cadaver constitutes a source of human-to-human transmission and if testing is performed to prevent human disease.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN190025 | OraQuick Ebola Rapid Antigen Test | OraSure Technologies, Inc. | Oct 10, 2019 | DENG |
Top Applicants
- OraSure Technologies, Inc. — 1 clearance
