510(k) DEN180069
DEN180069 is an FDA 510(k) premarket notification submitted by InBios International, Inc. for the device "ZIKV Detect 2.0 IgM Capture ELISA". The FDA issued a decision of De Novo Granted on May 23, 2019. The device falls under product code QFO (Zika Virus Serological Reagents), a Class II device regulated under 21 CFR 866.3935. InBios International, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 23, 2019
- Date Received
- December 26, 2018
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Zika Virus Serological Reagents
- Device Class
- Class II
- Regulation Number
- 866.3935
- Review Panel
- MI
- Submission Type
Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The device aids in the presumptive clinical diagnosis of Zika virus infection in conjunction with other clinical and laboratory findings.