FDA device listing
Simplexa Flu A/B & RSV Direct Simplexa Flu A/B & RSV Positive Control Pack
FDA device listing 1833890780 · DiaSorin Molecular LLC
Key facts
| Proprietary names | Simplexa Flu A/B & RSV Direct Simplexa Flu A/B & RSV Positive Control Pack |
|---|---|
| Owner/operator | DiaSorin Molecular LLC |
| Owner/operator number | 9089763 |
| Premarket submissions | K152408 |
| Product codes | OCC |
| Device names | OCC - Respiratory Virus Panel Nucleic Acid Assay System |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3980 |
| 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
- None 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