The following data is part of a De Novo classification by Inbios Intl., Inc. with the FDA for Denv Detect Igm Capture Elisa.
| DeNovo ID | DEN100020 |
| Device Name: | DENV DETECT IGM CAPTURE ELISA |
| Classification | Dengue Serological Reagents |
| Applicant | INBIOS INTL., INC. 562 1st. Ave. South, Suite 600 Seattle, WA 98104 |
| Contact | Estela I Raychaudhuri |
| Product Code | OSU |
| CFR Regulation Number | 866.3945 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K100534 |
| Review Advisory Board | Microbiology |
| Classification Advisory | Microbiology |
| Type | Post-NSE |
| Date Received | 2010-10-20 |
| Decision Date | 2011-04-08 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |