FDA device listing
?-Hydroxybutyrate 21 Bi-Level Controls,?-Hydroxybutyrate 21 Tri-Level Controls
FDA device listing 1295169435 · DIASYS DIAGNOSTIC SYSTEMS GMBH
Key facts
| Proprietary names | ?-Hydroxybutyrate 21 Bi-Level Controls,?-Hydroxybutyrate 21 Tri-Level Controls |
|---|---|
| Owner/operator | DIASYS DIAGNOSTIC SYSTEMS GMBH |
| Owner/operator number | 9105042 |
| Product codes | JJX |
| Device names | JJX - Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1660 |
| Review panels | Clinical Chemistry |
| Registered establishments | DIASYS DIAGNOSTIC SYSTEMS GMBH |
| Establishment registrations | 3006644620 |
| FEI numbers | 3006644620 |
| Establishment operations | Contract Manufacturer, 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