FDA device listing
Dimension Vista C3 Flex,Dimension Vista C4 Flex
FDA device listing 1234222336 · SIEMENS HEALTHCARE DIAGNOSTICS INC.
Key facts
| Proprietary names | Dimension Vista C3 Flex,Dimension Vista C4 Flex |
|---|---|
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Owner/operator number | 9096044 |
| Premarket submissions | K061852 |
| Product codes | CZW, DBI, JIX, JJY |
| Device names | CZW - Complement C3, Antigen, Antiserum, Control, DBI - Complement C4, Antigen, Antiserum, Control, JIX - Calibrator, Multi-Analyte Mixture, JJY - Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1150, 862.1660, 866.5240 |
| Review panels | Clinical Chemistry, Immunology |
| Registered establishments | Siemens Healthcare Diagnostics Products GmbH |
| Establishment registrations | 9610806 |
| FEI numbers | 3001644026 |
| Establishment operations | Manufacturer |
| 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