FDA device listing
MOL3950 Simplexa C. auris Direct,MOL3960 Simplexa C. auris Positive Control Pack,MOL5390 Simplexa C. auris Sample Prep…
FDA device listing 1644229901 · DiaSorin Molecular LLC
Key facts
| Proprietary names | MOL3950 Simplexa C. auris Direct,MOL3960 Simplexa C. auris Positive Control Pack,MOL5390 Simplexa C. auris Sample Prep Kit |
|---|---|
| Owner/operator | DiaSorin Molecular LLC |
| Owner/operator number | 9089763 |
| Premarket submissions | DEN230092 |
| Product codes | SBT |
| Device names | SBT - Device To Detect Microbial Colonization Directly From Clinical Specimens. |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3967 |
| Review panels | Microbiology |
| Registered establishments | DiaSorin Molecular LLC |
| Establishment registrations | 2023365 |
| FEI numbers | 2023365 |
| 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