← FDA Medical Device Classifications
Reagents, Non-Variola Orthopoxvirus Nucleic Acid.
QTQ · Not classified · Unknown
Classification
FDA Product Code QTQDevice 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 non-variola Orthopoxvirus and/or diagnosis of Monkeypox in human clinical specimens.
Market data
Cleared 510(k) submissions 0
Registered establishments 2
Source
Authoritative FDA Device Classification database Machine JSON-LD · Markdown
FDA medical device classification · AI Analytics CC0 1.0