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| EMDDB code |
21692
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| Basic UDI-DI |
6438153BU00161BS
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| Seadme klass |
In vitro diagnostikameditsiiniseade
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| Medical Device Nomenclature |
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| Risk class |
Class B
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| Appliance |
-
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| Device name (in Estonian) |
Gamma-GT (IFCC)
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| Device name (in English) |
Gamma-GT (IFCC)
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| Intended use (is Estonian) |
Gamma-GT aktiivsuse kvantitatiivseks in vitro määramiseks inimese vereseerumis ja -plasmas Thermo Scientific™-u analüsaatorite Indiko™ ning Konelab™ automatiseeritud protseduuridega. Analüüsi Gamma-GT kasutatakse hepatobiliaarsete haiguste diagnoosimisel ja jälgimisel patsientidel. Analüüsi Gamma-GT kasutatakse samuti erinevate maksahaiguste, -kahjustuste ja kliiniliste häirete, nagu primaarne või sekundaarne maksavähk, alkoholhepatiit, diagnoosimisel, kontrollimisel ja jälgimisel patsientidel. Analüüsi Gamma-GT kasutatakse akuutse ja kroonilise pankreatiidi ning pankreasevähi (eriti kui see on seotud hepatobiliaarse obstruktsiooniga) diagnoosimisel ja jälgimisel patsientidel. Lisaks on analüüs Gamma-GT kasutusel hepatotoksiinide (kemikaalid, orgaanilised lahustid) ja ravimimürgistuste (paratsetamool, antikonvulsandid, nagu karbamasepiin, fenütoiin ja fenobarbitaal) tuvastamisel ja mõjude jälgimisel patsientidel.
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| Intended use (in English) |
For in vitro diagnostic use in the quantitative determination of Gamma-GT activity in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Gamma-GT test is used in diagnosis and monitoring of hepatobiliary diseases, in patients. The Gamma-GT test is also used in diagnosis, screening and monitoring of various diseases, injuries and clinical disorders of the liver, such as primary or secondary liver neoplasms or alcoholic hepatitis, in patients. The Gamma-GT test is also used in diagnosis and monitoring of acute and chronic pancreatitis and pancreatic malignancies (in particular if associated with hepatobiliary obstruction), in patients. Furthermore, the Gamma-GT test is used in detection and monitoring of the effects of hepatotoxins (chemicals, organic solvents) and drug intoxications (paracetamol, anticonvulsant drugs including carbamazepine, phenytoin and phenobarbital), in patients.
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| Type/model/article number |
981778
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| Notified body |
0197
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| Manufacturer |
Thermo Fisher Scientific Oy
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| In register from |
03/12/2025
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| Entry status |
Active
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| Reimbursed by EHIF |
Tervisekassa soodustus puudub
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