The following data is part of a De Novo classification by Id-fish Technology, Inc with the FDA for Id-fish Plasmodium Genus Test Kit, Id-fish Plasmodium Falciparum And P. Vivax Combo Test Kit.
| DeNovo ID | DEN160025 |
| Device Name: | ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium Falciparum And P. Vivax Combo Test Kit |
| Classification | Fish (fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp. |
| Applicant | ID-FISH TECHNOLOGY, INC 797 San Antonio Road Palo Alto, CA 94303 |
| Contact | Jyotsna Shah |
| Product Code | PYN |
| CFR Regulation Number | 866.3367 [🔎] |
| 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 | 2016-06-27 |
| Decision Date | 2017-08-18 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |