FDA device listing
QX600Dx Droplet Reader,QXDx AutoDG Supermix Pack B,QXDx Automated Droplet Generator IVD,QXDX Droplet Reader
FDA device listing 1844500882 · Bio-Rad Laboratories, Inc.
Key facts
| Proprietary names | QX600Dx Droplet Reader,QXDx AutoDG Supermix Pack B,QXDx Automated Droplet Generator IVD,QXDX Droplet Reader |
|---|---|
| Owner/operator | Bio-Rad Laboratories, Inc. |
| Owner/operator number | 9929003 |
| Product codes | PHG |
| Device names | PHG - Droplet Digital Pcr System |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.2570 |
| Review panels | Clinical Chemistry |
| Registered establishments | Bio-Rad Laboratories, Inc. |
| Establishment registrations | 2915274 |
| FEI numbers | 2915274 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database