← FDA Medical Device Classifications
Reagents, Monkeypox Virus Nucleic Acid.
QTP · Not classified · Unknown
Classification
- FDA Product Code
QTP- Device 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 monkeypox virus and/or diagnosis of Monkeypox in human clinical specimens
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 5
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown