OZB
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dengue Nucleic Acid Amplification Assay (Naat)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3946
- Medical specialty
- Microbiology
- FDA 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).
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| Record | Firm | Date |
|---|---|---|
| CDC DENV-1-4 REAL TIME RT-PCT ASSAY (DEN120012) | Centers for Disease Control and Prevention | 2012-05-24 |
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