FDA device listing
LIAISON BRAHMS Control PCT II GEN,LIAISON BRAHMS PCT II GEN,LIAISON BRAHMS PCT II GEN Verifiers
FDA device listing 1679333578 · DiaSorin Inc.
Key facts
| Proprietary names | LIAISON BRAHMS Control PCT II GEN,LIAISON BRAHMS PCT II GEN,LIAISON BRAHMS PCT II GEN Verifiers |
|---|---|
| Owner/operator | DiaSorin Inc. |
| Owner/operator number | 9051149 |
| Premarket submissions | K173683 |
| Product codes | JJX, NTM, PMT, PRI |
| Device names | JJX - Single (Specified) Analyte Controls (Assayed And Unassayed), NTM - Antigen, Inflammatory Response Marker, Sepsis, PMT - Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens, PRI - Procalcitonin Assay |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1660, 866.3210, 866.3215 |
| Review panels | Clinical Chemistry, Microbiology |
| Registered establishments | DiaSorin Italia S.p.A. |
| Establishment registrations | 9610240 |
| FEI numbers | 3002808212 |
| 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