FDA device listing
Stratus CS Acute Care CKMB CalPak,Stratus CS Acute Care CKMB TestPak,Stratus CS Acute Care CTNI CalPak,Stratus CS Acute…
FDA device listing 1788864766 · SIEMENS HEALTHCARE DIAGNOSTICS INC.
Key facts
| Proprietary names | Stratus CS Acute Care CKMB CalPak,Stratus CS Acute Care CKMB TestPak,Stratus CS Acute Care CTNI CalPak,Stratus CS Acute Care CTNI TestPak,Stratus CS Acute Care MYO CalPak,Stratus CS Acute Care MYO TestPak |
|---|---|
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Owner/operator number | 9096044 |
| Premarket submissions | K051650 |
| Product codes | DDR, JHX, JIT, MMI |
| Device names | DDR - Myoglobin, Antigen, Antiserum, Control, JHX - Fluorometric Method, Cpk Or Isoenzymes, JIT - Calibrator, Secondary, MMI - Immunoassay Method, Troponin Subunit |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1150, 862.1215, 866.5680 |
| Review panels | Clinical Chemistry, Immunology |
| Registered establishments | Siemens Healthcare Diagnostics Inc, SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Establishment registrations | 2517506, 3002637618 |
| FEI numbers | 2517506, 3002637618 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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