FDA device listing
ADVIA Centaur Creatine Kinase MB Calibrator (CKMB CAL),ADVIA Centaur Creatine Kinase MB (CKMB),ADVIA Centaur Creatine…
FDA device listing 1067728015 · SIEMENS HEALTHCARE DIAGNOSTICS INC.
Key facts
| Proprietary names | ADVIA Centaur Creatine Kinase MB Calibrator (CKMB CAL),ADVIA Centaur Creatine Kinase MB (CKMB),ADVIA Centaur Creatine Kinase MB Diluent (CKMB Dil),ADVIA Centaur Creatine Kinase MB Master Curve Material (CKMB MCM),Atellica IM Creatine Kinase MB Calibrator (CKMB CAL),Atellica IM Creatine Kinase MB (CKMB),Atellica IM Creatine Kinase MB Diluent (CKMB Dil),Atellica IM Creatine Kinase MB Master Curve… |
|---|---|
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Owner/operator number | 9096044 |
| Premarket submissions | K962126 |
| Product codes | JHS, JHX |
| Device names | JHS - Differential Rate Kinetic Method, Cpk Or Isoenzymes, JHX - Fluorometric Method, Cpk Or Isoenzymes |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1215 |
| Review panels | Clinical Chemistry |
| Registered establishments | Siemens Healthcare Diagnostics Inc. |
| Establishment registrations | 1219913, 2432235 |
| FEI numbers | 1219913, 2432235 |
| Establishment operations | Complaint File Establishment, Specification Developer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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