Eu Ivdd Eu Ivd General No Longer On The Market 🇫🇮 Finland

GP Reader NT

Biohit Oyj · 🇫🇮 Finland
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
06419587740454
Basic UDI-DI Code
B-06419587740454
Reference
740450
Device Types
None provided
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
No Longer On The Market
Manufacturer
Biohit Oyj

Additional Description

GP Reader NT is a bench top instrument for the quantitative measurement of fluorescence signals from multichannel lateral flow cassettes. GP Reader NT is intended to be used in conjunction with GastroPanel quick test NT (REFs 602410, 602420) for diagnosing Helicobacter pylori infection and atrophic gastritis (AG) from patients with dyspeptic symptoms or at risk to develop malignant cellular changes in stomach mucosa. In addition, GP Reader NT with GastroPanel quick test NT aids in screening conditions that necessitate additional examination or treatment from healthy stomach mucosa. GP Reader NT is to be used by healthcare professionals, either in a laboratory-based or point of care (POC) setting. For in vitro diagnostic use.

CND Nomenclature Codes

Code Description
W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER

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