Eu Ivdr Eu Ivd Class A On The Market 🇰🇷 South Korea

GAMMA COUNTERS

Shinjin Medics Inc. · 🇰🇷 South Korea
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
08806120502132
Basic UDI-DI Code
880612050213BM
Reference
MR01
Device Types
New device
Regulation
Eu Ivdr
Classification
Eu Ivd Class A
Status
On The Market
Manufacturer
Shinjin Medics Inc.

Additional Description

The intended purpose of MESSIAH R4200 is dedicated instrument for fully automated processing of radioimmuno assays. It is designed in a radioimmunoassay to measure the amount of radioactivity in tubes with an isotope–labeled tracer of antigen or antibody in, and calculate automatically the results of qualitative, quantitative and semi-quantitative tests. The instrument can be used for screening, monitoring, diagnosis or aid to diagnosis, prognosis, prediction, companion diagnostic depending on the purpose of use of the reagent used together. For professional use only. Solid and liquid sample. Usually Serum or Plasma used. The device is not a companion diagnostic.

CND Nomenclature Codes

Code Description
W0201020203 GAMMA COUNTERS

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