Reagents, 2019-Novel Coronavirus Nucleic Acid
Reagents for 2019-Novel Coronavirus Nucleic Acid detection are nucleic acid-based in vitro diagnostic devices for the detection of SARS-CoV-2 (2019-nCoV) and/or the diagnosis of 2019-nCoV infection in human clinical specimens. These devices are classified as Not Classified (Class N), reviewed by the Microbiology panel, with no regulation number assigned; this classification reflects emergency authorization status during the COVID-19 public health emergency. The product code is QJR. The devices are not implants and are not flagged as life-sustaining.
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Basic Information
- Product Code
- QJR
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- MI
- Submission Type
- 8
Device Characteristics
Definition
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.
Unclassified Reason
11
FEI Numbers
This FDA classification entry is associated with 58 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 58 registration numbers. Click on an entry to view related FDA registrations.