FDA device listing
Premier Resolution Analyzer,Premier Resolution Assay Components
FDA device listing 1609071391 · TRINITY BIOTECH, PLC
Key facts
| Proprietary names | Premier Resolution Analyzer,Premier Resolution Assay Components |
|---|---|
| Owner/operator | TRINITY BIOTECH, PLC |
| Owner/operator number | 9025161 |
| Premarket submissions | K222635 |
| Product codes | GKA |
| Device names | GKA - Abnormal Hemoglobin Quantitation |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.7415 |
| Review panels | Hematology |
| Registered establishments | Trinity Biotech do Brasil, Trinity Biotech (Primus Corporation dba Trinity Biotech) |
| Establishment registrations | 1931251, 3032069621 |
| FEI numbers | 1931251, 3032069621 |
| Establishment operations | Contract Manufacturer, 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