FDA device listing
Mag-Bind® Blood DNA HV Kit CE IVD,Mag-Bind® Blood & Tissue DNA Kit CE IVD,Mag-Bind® cfDNA Kit CE IVD,MagBinder…
FDA device listing 1281964256 · Omega Bio-Tek
Key facts
| Proprietary names | Mag-Bind® Blood DNA HV Kit CE IVD,Mag-Bind® Blood & Tissue DNA Kit CE IVD,Mag-Bind® cfDNA Kit CE IVD,MagBinder Fit24,Mag-Bind® Viral DNA/RNA Xpress Kit CE IVD,MBFit24™ Blood & Tissue DNA Kit CE IVD,MBFit24™ cfDNA Kit CE IVD |
|---|---|
| Owner/operator | Omega Bio-Tek |
| Owner/operator number | 10090841 |
| Product codes | JJH |
| Device names | JJH - Clinical Sample Concentrator |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2310 |
| Review panels | Clinical Chemistry |
| Registered establishments | OMEGA BIO-TEK |
| Establishment registrations | 3014290238 |
| FEI numbers | 3014290238 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| 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