Reagents, 2019-Novel Coronavirus Nucleic Acid
- US Product Code (FDA)
- QJRView Product Code Classification →
- US Risk Class (FDA)
- Class N
- US Regulation (CFR)
- 21 CFRView CFR Regulation →
- Medical specialty
- Unknown
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens.
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Reagents, 2019-Novel Coronavirus Nucleic Acid is a medical device type in the Unknown 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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