OSU
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dengue Serological Reagents
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3945
- Medical specialty
- Microbiology
- FDA definition
- Dengue virus serological reagents are devices that consist of antigens and antisera for the detection of anti-dengue antibodies, individuals that have signs and symptoms consistent with dengue. The detection aids in the clinical laboratory diagnosis of dengue fever or dengue hemorrhagic fever caused by dengue virus. The device is intended for use in the presumptive diagnosis of patients in conjunction with other clinical and laboratory findings.
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| Record | Firm | Date |
|---|---|---|
| DENV DETECT IGM CAPTURE ELISA (DEN100020) | Inbios Intl., Inc. | 2011-04-08 |
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Every clearance here is in the API, with alerts when new ones post.