Data / Medical devices / United States / CD Diagnostics, Inc
CD Diagnostics, Inc: FDA-registered device maker in Claymont, DE, United States, 1 510(k) clearance
CD Diagnostics, Inc is registered with the FDA (registration 3011171357) in Claymont, DE, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 11, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011171357
- Address
- 650 Naamans Road Suite 100, Claymont, DE, United States, 19703
- Owner or operator
- CD Diagnostics, Inc (10047552)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- October 6, 2014
- Registered through
- 2027
- Brand names listed
- Synovasure Alpha Defensin Control Kit, Synovasure Alpha Defensin ELISA Test, Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit and Synovasure Alpha Defensin Control Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lateral Flow Immunochromatography Assay For Host Infection Biomarkers | QGN | 2 | Manufacturer | accessdata.fda.gov |
| Multiple Osteoarticular Pathogen Antigen Kit | QHV | N | Manufacturer for export | accessdata.fda.gov |
| Test For Periprosthetic Joint Infection | PIL | N | Manufacturer for export | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 11, 2021 | K212204 | Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit | QGN | Substantially Equivalent | Cd Diagnostics, Inc. | accessdata.fda.gov |
Updated August 11, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.