Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
- US Product Code (FDA)
- QIDView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 866.4002View CFR Regulation →
- Medical specialty
- Microbiology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- Yes
- Third party review
- Not Eligible
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.
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Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens 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. This device type includes life-sustaining products.
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