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2 results for Anti-HBc-Tests
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German
Portuguese
Bei
Blut-Screening-Produkten
(
mit
Ausnahme
der
HBsAg-
und
der
Anti-HBc-Tests
)
muss
das
Produkt
,
das
die
CE-Kennzeichnung
erhalten
soll
,
für
alle
echt
positiven
Proben
einen
positiven
Befund
anzeigen
(
Tabelle
1). [EU]
No
caso
dos
dispositivos
para
testes
de
rastreio
do
sangue
(à
excepção
dos
testes
de
HBsAg
e
anti-HBc
),
todas
as
amostras
verdadeiras
positivas
devem
ser
identificadas
como
positivas
pelo
dispositivo
que
ostentará
a
marcação
CE
(quadro 1).
Bei
HBsAg-
und
Anti-HBc-Tests
muss
das
neue
Produkt
eine
Gesamtleistung
erbringen
,
die
derjenigen
des
etablierten
Produkts
(
vgl
.
Grundsatz
3.1.4)
zumindest
gleichwertig
ist
. [EU]
No
caso
dos
testes
HBsAg
e
anti-HBc
, o
novo
dispositivo
terá
um
comportamento
funcional
global
pelo
menos
equivalente
ao
do
dispositivo
reconhecido
(ver
ponto
3.1.4.).
Sentences marked by [EU] derived from
DGT Multilingual Translation Memory
. The European Commission retains ownership of the copyright in the original data.
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