FDA device listing
Dimension Aspartate Aminotransferase Flex,Dimension Glucose Flex,Dimension RxL Max with HM & STM,Dimension RxL Max (with…
FDA device listing 1846398508 · SIEMENS HEALTHCARE DIAGNOSTICS INC.
Key facts
| Proprietary names | Dimension Aspartate Aminotransferase Flex,Dimension Glucose Flex,Dimension RxL Max with HM & STM,Dimension RxL Max (with or without HM),Dimension RxL (with or without HM),Dimension Thyroid Stimulating Hormone Flex,Dimension Xpand Plus (with or without HM),Dimension Xpand (with or without HM),QuikLYTE IMT (Na+/K+/Cl-) |
|---|---|
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Owner/operator number | 9096044 |
| Premarket submissions | K112999 |
| Product codes | CEM, CEW, CFR, CGZ, CIT, JGS, JJE |
| Device names | CEM - Electrode, Ion Specific, Potassium, CEW - Radioimmunoassay, Parathyroid Hormone, CFR - Hexokinase, Glucose, CGZ - Electrode, Ion-Specific, Chloride, CIT - Nadh Oxidation/Nad Reduction, Ast/Sgot, JGS - Electrode, Ion Specific, Sodium, JJE - Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1100, 862.1170, 862.1345, 862.1545, 862.1600, 862.1665, 862.2160 |
| Review panels | Clinical Chemistry |
| Registered establishments | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Establishment registrations | 2517506 |
| FEI numbers | 2517506 |
| 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