The following data is part of a De Novo classification by Cd Diagnostics Inc. with the FDA for Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit.
| DeNovo ID | DEN180032 |
| Device Name: | Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit |
| Classification | Lateral Flow Immunochromatography Assay For Host Infection Biomarkers |
| Applicant | CD Diagnostics Inc. 650 Naamans Road, Suite 100 Claymount, DE 19703 |
| Contact | Sujith Kallur |
| Product Code | QGN |
| CFR Regulation Number | 866.3230 [🔎] |
| 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 | 2018-06-29 |
| Decision Date | 2019-05-23 |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868358852 | DEN180032 | 000 |
| 00887868540653 | DEN180032 | 000 |
| 00887868540677 | DEN180032 | 000 |
| 00887868540684 | DEN180032 | 000 |
| 00887868540691 | DEN180032 | 000 |
| 00887868358814 | DEN180032 | 000 |
| 00887868358821 | DEN180032 | 000 |
| 00887868358838 | DEN180032 | 000 |
| 00887868358845 | DEN180032 | 000 |
| 70887868540669 | DEN180032 | 000 |