FDA device listing
N-GENEOUS LDL-ST CHOLESTEROL
FDA device listing 1127105322 · SEKISUI MEDICAL CO., LTD.
Key facts
| Proprietary names | N-GENEOUS LDL-ST CHOLESTEROL |
|---|---|
| Owner/operator | SEKISUI MEDICAL CO., LTD. |
| Owner/operator number | 9030526 |
| Product codes | JIS, JJX, MRR |
| Device names | JIS - Calibrator, Primary, JJX - Single (Specified) Analyte Controls (Assayed And Unassayed), MRR - System, Test, Low Density, Lipoprotein |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1150, 862.1475, 862.1660 |
| Review panels | Clinical Chemistry |
| Registered establishments | SEKISUI MEDICAL CO., LTD. Tsukuba Plant |
| Establishment registrations | 3003539867 |
| FEI numbers | 3006769061 |
| Establishment operations | Contract 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