OSU — Dengue Serological Reagents Class II
FDA product code OSU covers "Dengue Serological Reagents", 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
- OSU
- Device Class
- Class II
- Regulation Number
- 866.3945
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN100020 | inbios intl | DENV DETECT IGM CAPTURE ELISA | April 8, 2011 |