The following materials are valid only for users based in the United States or subjected to the US FDA regulations on in-vitro diagnostics (IVD) devices.
| e-IFU | latest revision | 510(k) Substantial Equivalence Determination Decision Summary |
|---|---|---|
| ComASP Cefiderocol 0.008-128 (US version) | rev.0 - 05/2023 |  |