FDA device listing
Calibrator, Secondary
FDA device listing 1775697447 · Sekisui Diagnostics, LLC
Key facts
| Owner/operator | Sekisui Diagnostics, LLC |
|---|---|
| Owner/operator number | 10035388 |
| Product codes | JIT, JJX, LCP, PDJ |
| Device names | JIT - Calibrator, Secondary, JJX - Single (Specified) Analyte Controls (Assayed And Unassayed), LCP - Assay, Glycosylated Hemoglobin, PDJ - Hemoglobin A1c Test System |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1150, 862.1373, 862.1660, 864.7470 |
| Review panels | Clinical Chemistry, Hematology |
| Registered establishments | Sekisui Diagnostics P.E.I. Inc. |
| Establishment registrations | 8020316 |
| FEI numbers | 3002806809 |
| 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