FDA device listing
BIOLIS 30i,DZ-Lite c270,IMMTOX 270,MyeLyte Touch
FDA device listing 1027773834 · Biolis Medical Corp.
Key facts
| Proprietary names | BIOLIS 30i,DZ-Lite c270,IMMTOX 270,MyeLyte Touch |
|---|---|
| Owner/operator | Biolis Medical Corp. |
| Owner/operator number | 9060135 |
| Premarket submissions | K103531 |
| Product codes | CFR, JJE |
| Device names | CFR - Hexokinase, Glucose, JJE - Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1345, 862.2160 |
| Review panels | Clinical Chemistry |
| Registered establishments | Biolis Medical Corp. |
| Establishment registrations | 3004378326 |
| FEI numbers | 3004378326 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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