Product code QCU
- Device name
- Dengue Virus Antigen Assay
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3945
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Qualitative detection of Dengue virus antigen in human serum or plasma collected from human patients with signs and symptoms consistent with Dengue virus infection
- Source
- FDA openFDA device classification dataset