The following data is part of a De Novo classification by Inbios International, Inc. with the FDA for Zikv Detect 2.0 Igm Capture Elisa.
| DeNovo ID | DEN180069 |
| Device Name: | ZIKV Detect 2.0 IgM Capture ELISA |
| Classification | Zika Virus Serological Reagents |
| Applicant | InBios International, Inc. 307 Westlake Ave N, Suite 300 Seattle, WA 98109 |
| Contact | Estela Raychaudhuri |
| Product Code | QFO |
| CFR Regulation Number | 866.3935 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Microbiology |
| Classification Advisory | Microbiology |
| Type | Direct |
| Date Received | 2018-12-26 |
| Decision Date | 2019-05-23 |
| Reclassification Order: | Reclassification Order |