QCU — Dengue Virus Antigen Assay Class II
FDA product code QCU covers "Dengue Virus Antigen Assay", a Class II medical device regulated under 21 CFR 866.3945. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QCU
- Device Class
- Class II
- Regulation Number
- 866.3945
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K181473 | inbios international | DENV Detect NS1 ELISA | August 27, 2018 |