Eu Ivdr Eu Ivd Class A On The Market 🇯🇵 Japan

PATHFAST

PHC Corporation · 🇯🇵 Japan
Devices (same UDI-DI)
3
Certificates
0
Countries
0
Notified Bodies
0

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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