FDA device listing
Atellica CH DRUG CAL II,Emit II Plus Specialty Multi Drug Calibrator/Control Level 1,Emit II Plus Specialty Multi Drug…
FDA device listing 1279263320 · SIEMENS HEALTHCARE DIAGNOSTICS INC.
Key facts
| Proprietary names | Atellica CH DRUG CAL II,Emit II Plus Specialty Multi Drug Calibrator/Control Level 1,Emit II Plus Specialty Multi Drug Calibrator/Control Level 2,Emit II Plus Specialty Multi Drug Calibrator/Control Level 3,Emit II Plus Specialty Multi Drug Calibrator/Control Level 4 |
|---|---|
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Owner/operator number | 9096044 |
| Product codes | DLJ |
| Device names | DLJ - Calibrators, Drug Specific |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.3200 |
| Review panels | Clinical Toxicology |
| Registered establishments | Siemens Healthcare Diagnostics Inc., SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Establishment registrations | 2432235, 2517506 |
| FEI numbers | 2432235, 2517506 |
| Establishment operations | Manufacturer, Specification Developer |
| 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