Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
- US Product Code (FDA)
- QMVView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 866.3966View CFR Regulation →
- Medical specialty
- Microbiology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
A device to detect and identify selected microbial agents that cause acute febrile illness is identified as a in vitro device intended for the detection and identification of microbial agents in human clinical specimens from patients with signs and symptoms of acute febrile illness who are at risk for exposure or who may have been exposed to these agents. It is intended to aid in the diagnosis of acute febrile illness in conjunction with other clinical, epidemiologic, and laboratory data, including patient travel, pathogen endemicity, or other risk factors.
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Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness 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.
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