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Terviseamet

Medical device

MSA code 17847
Basic UDI-DI
Seadme klass In vitro diagnostikameditsiiniseade
Medical Device Nomenclature
Risk class Class A
Appliance -
Device name (in Estonian) QuikRead go Instrument
Device name (in English) QuikRead go Instrument
Intended use (is Estonian) QuikRead go® Instrument on automatiseeritud instrument, mis on loodud ja kalibreeritud nii fotomeetrilisteks kui ka turbidimeetrilisteks mõõtmisteks.
Instrument on mõeldud kasutamiseks QuikRead go® reagendikomplektidega analüütide kvantitatiivseks ja kvalitatiitvseks määramiseks sellistest
inimese proovidest nagu täisveri, seerum, plasma, kurguproov ja väljaheited eesmärgiga diagnoosida ja jälgida ravi kulgu.
Intended use (in English) QuikRead go® Instrument is an automated instrument
designed and calibrated for both photometric
and turbidimetric measurements. The instrument
is intended for quantitative and qualitative determination
of various QuikRead go® reagent kit analytes
from human samples such as whole blood,
serum, plasma, throat swabs and faecal samples
to be used as an aid in diagnosis and treatment
monitoring.
Type/model/article number 133893
Notified body NA
Manufacturer Aidian Oy
In register from 06/28/2022
Status Active
EHK soodustus EHK soodustus puudub
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