← FDA Medical Device Classifications
Reagents, 2019-Novel Coronavirus Nucleic Acid
QJR · Not classified · Unknown
Classification
FDA Product Code QJRDevice class Not classified
Regulation —
Review panel MI
Medical specialty Unknown
Submission type 8
GMP exempt N
Life sustaining N
Implant N
Third-party review N
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.
Market data
Cleared 510(k) submissions 0
Registered establishments 59
Source
Authoritative FDA Device Classification database Machine JSON-LD · Markdown
FDA medical device classification · AI Analytics CC0 1.0