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Zymo Research erhält CE IVD Kennzeichnung für sein Quick-DNA/RNA™ Viral MagBead Kit
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Nov 23, 2020, 04:36 ET

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Zuverlässige und sensible Virusreinigung zum Nachweis und zur Analyse von SARS-CoV-2-Viren  

IIRVINE, Kalif., 23. November 2020 /PRNewswire/ -- Zymo Research gab heute bekannt, dass sein Quick-DNA/RNA™ Viral MagBead Kit für den Vertrieb an den gemeinsamen Markt der Europäischen Union (EU) freigegeben wurde. Das Produkt ist konzipiert für die Hochdurchsatz-Reinigung von viraler DNA und/oder RNA aus biologischen Proben, die im DNA/RNA Shield.™ gelagert sind. Das DNA/RNA Shield™ wird zur Probensammlung, Nukleinsäurekonservierung und für die Deaktivierung von Krankheitserregern verwendet. Die isolierten hochwertigen Nukleinsäuren sind bereit für alle nachgelagerten Anwendungen wie Next-Gen-Sequencing und für den RT-qPCR-Nachweis.

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Zymo Research’s Quick-DNA/RNA™ Viral MagBead Kit has been cleared for in vitro diagnostic applications for use by EU member states.
Zymo Research’s Quick-DNA/RNA™ Viral MagBead Kit has been cleared for in vitro diagnostic applications for use by EU member states.

„Zymo Research spielt bei der Bekämpfung der aktuellen COVID-19 Pandemie eine bedeutende Rolle", sagte Stanislav Forman, ein Wissenschaftler bei Zymo Research. „Alle Produkte unseres COVID-19 Testablaufs sind nun CE IVD-gekennzeichnet; damit unterstützen wir unsere Klinik-Kunden in der EU und darüber hinaus."

Das CE IVD-markierte Quick-DNA/RNA™ Viral MagBead Kit erfüllt die Sicherheits-, Gesundheits- und Umweltschutz-Anforderungen der EU. Das Quick-Kit kann für die Reinigung viraler DNA/RNA - z.B. für SARS-CoV-2, das Virus, das COVID-19 verursacht – und für weitere Probenarten von Krankheitserregern verwendet werden. Das Kit ist Teil mehrerer Testabläufe für FDA EUA SARS-CoV-2, die von bekannten Unternehmen wie Illumina und Fulgent Genetics entwickelt wurden.

""Wir sind sehr erfreut, dass das Quick-DNA/RNA™ Viral MagBead Kit von Zymo Research die CE IVD Kennzeichnung von der EU erhalten hat," sagte Thiago Pinto Nogueira, Business Development Director von Veritas Bio. „In Brasilien heißt unsere Gesundheitsbehörde (ANVISA) Produkte mit der CE Kennzeichnung willkommen. Das erleichtert uns die Arbeit bei der örtlichen Registrierung von Produkten. Für unsere Kunden signalisiert die Kennzeichnung, dass dieses Produkt die Gesundheits- und Sicherheitsstandards erfüllt."

Nähere Informationen zum Quick DNA/RNA™ Viral MagBead Kit von Zymo Research finden Sie unter seiner website oder kontaktieren Sie das Unternehmen unter [email protected].

Informationen zu Zymo Research Corp.

Zymo Research ist ein Privatunternehmen, das die wissenschaftliche und diagnostische Gemeinschaft seit 1994 mit hochmodernen molekularbiologischen Werkzeugen beliefert. Das Motto des Unternehmens ist "The Beauty of Science is to Make Things Simple" (Das Schöne an der Wissenschaft ist, dass sie die Dinge vereinfacht), was sich in allen Produkten des Unternehmens widerspiegelt, von Epigenetik bis zu DNA/RNA-Reinigungstechnologien. Zymo Research wird historisch als führend im Bereich Epigenetik anerkannt, mit bahnbrechenden Leistungen durch neue Lösungen bei der Probensammlung, bei mikrobiometrischen Messungen, Diagnosegeräten und NGS-Technologien, die, bei einfacher Handhabung, hohe Qualität liefern. Folgen Sie Zymo Research auf Facebook, LinkedIn, Twitter und Instagram.

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