Basic Information
- Primary DI
- 04987595300929
- Basic UDI-DI Code
- 4987595PATHFASTSC
- Reference
- 300929
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- PHC Corporation
Additional Description
PATHFAST is a clinical laboratory instrument to measure various materials derived from patients. quickly and accurately using whole blood, plasma, serum or other body fluid as samples. PATHFAST is adaptable widely for use in hospital laboratory, clinics and even bedsides, because it is small and easy to use with short assay time. Reagents used with PATHFAST are developed, manufactured and supplied in a specially prepared cartridge per test by LSI Medience Corporation. The principle of measurement employed for the reagent system is CLEIA (Chemi luminescence Enzyme Immuno-Assay). So, the PATHFAST system realizes the high sensitivity and high accuracy of analysis. PATHFAST instrument utilizes Magtration® technology for B/F separation in several reaction steps.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201069099 | VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER |
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Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class A) and regulation (EU IVDR).