QCU
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dengue Virus Antigen Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3945
- Medical specialty
- Microbiology
- FDA 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
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| Record | Firm | Date |
|---|---|---|
| DENV Detect NS1 ELISA (K181473) | InBios International, Inc. | 2018-08-27 |
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