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Terviseamet
FOR VISUALLY IMPAIRED

Medical device

MSA code 18064
Basic UDI-DI
Seadme klass In vitro diagnostikameditsiiniseade
Medical Device Nomenclature
Risk class General IVD 98/79/EC
Appliance -
Device name (in Estonian) Aβ(1–42) CAL-RVC pakk
Device name (in English) Aβ(1–42) CAL-RVC pack
Intended use (is Estonian) Aβ(1–42) CAL-RVC-d peab kasutama koos INNOTEST β-AMYLOID(1–42) REF 81576-ga
β-amüloidi(1–42) kvantifitseerimiseks inimese liikvorist.
Intended use (in English) The Aβ(1-42) CAL-RVC should be used in combination with INNOTEST β-AMYLOID(1-42)
REF 81576 for the quantification of β-amyloid(1-42) in human cerebrospinal fluid.
Type/model/article number 81577
Manufacturer Fujirebio Europe N.V.
In register from 09/23/2022
Entry status Active
Reimbursed by EHIF Tervisekassa soodustus puudub
Documents related to medical device model
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