510(k) DEN100020
DEN100020 is an FDA 510(k) premarket notification submitted by Inbios Intl., Inc. for the device "DENV DETECT IGM CAPTURE ELISA". The FDA issued a decision of De Novo Granted on April 8, 2011. The device falls under product code OSU (Dengue Serological Reagents), a Class II device regulated under 21 CFR 866.3945. Inbios Intl., Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 8, 2011
- Date Received
- October 20, 2010
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dengue Serological Reagents
- Device Class
- Class II
- Regulation Number
- 866.3945
- Review Panel
- MI
- Submission Type
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.