OZB — Dengue Nucleic Acid Amplification Assay (Naat) Class II
FDA product code OZB covers "Dengue Nucleic Acid Amplification Assay (Naat)", a Class II medical device regulated under 21 CFR 866.3946. 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
- OZB
- Device Class
- Class II
- Regulation Number
- 866.3946
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
A qualitative in vitro diagnostic assay for the detection of dengue virus serotypes 1, 2, 3 or 4 in serum or plasma specimens collected from human patients with signs and symptoms consistent with dengue (mild or severe).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN120012 | centers for disease control and prevention | CDC DENV-1-4 REAL TIME RT-PCT ASSAY | May 24, 2012 |