GNW ad hoc: QIAGEN erhält European IVDR certification for syndromic test systems QIAstat-Dx and custom tests ()

^VENLO, Netherlands, September 26, 2024 (GLOBE NEWSWIRE) — QIAGEN (NYSE: QGEN;

Frankfurt Prime Standard: QIA) cannot be used, this is the seine

syndromic test systems QIAstat-Dx are tests that are new

EU Regulation on In-vitro Diagnostics (IVDR) that implements CE-Kennzeichnung

haben.

The Zertifizierung is the most comprehensive QIAstat-Dx Analyzer, then

QIAstat-Dx Rise, also Panels zum Nachweis von Gastrointestinal-en

Atemwegserkrankungen. Dieser Erfolg unterstreicht QIAGENs Bekenntnis zur

Succession of high safety, quality and performance standards. Thats

Unternehmen hat bereits 80 Prozent von über 180 Products op de nouvelle

regulatory framework work.

The new IVDR Regulation on the Safety, Quality and Wirksamkeit of In-

vitro-Diagnostika (IVD) gewährleisten, was von unabhängigen Organizationen in

der EU, den sogenannten Benannten Stellen (notified bodies), überwacht wird. I am

These parts are now converted into the Risk Costs of A for the lightest bis D

for the highest risk input. The QIAstat-Dx system QIAstat-Dx Analyzer 2.0

and QIAstat-Dx can be classified as class A, whährend

of QIAstat-Dx Gastrointestinal Panel 2 as a class C product eintufted.

The QIAstat-Dx Respiratory Panel Plus is available as a class D and product

Due to the high classification of risk categories, there were a number of more QIAGENs

Fähigkeit unterstreicht, highest regulatory provisions in Europe zu

hereditary. The Einreichung des QIAstat-Dx Meningitis/Enzephalitis-Panels zur

IVDR certification is granted in the kommenden Monaten erwartet.

?The IVDR certification of the QIAstat-Dx system and panels has been established

bedeuten Meilenstein für QIAGEN dar,” said Fernando Beils, Senior Vice

President and Leader of the Geschäftsbereichs Molekulare Diagnostik at QIAGEN.

?Diese Zertifizierung nach dem neuen, strengthening of the EU-Rechtrahmen understreicht

our commitment, medical care and quick solutions

for the syndromic test of the view you want to set, if you wish

could be lost. In the context of the installation of over 180 products from the IVDR

Verordnung bleiben wir unserem Ziel verpflichtet, de Patientenversorgung more

so spoiled. You may be performing clinical treatments and treatments

a comprehensive Portfolio of diagnostic solutions, which represent the highest standards

Bezug auf Sicherheit, Qualität und Leistung entsprechen.”

The QIAstat-Dx-System uses the Multiplex? Really? PCR technology to make it happen

Recognition and identification of more pathogens and sweeterness

Ergebnisse in a different state. I love a lot more dating,

simple Cycle-Threshold (Ct)-Werte and Amplification curves, directly on

the touchscreen of the devices. These changes and präzisen ergebnisse ermöglichen

If health care services are provided, basic treatment care will be taken,

who zB has the insight into an unknown antibiotic infection, when virus infections

were night-wishers. Damit could decide on treatment options and furthermore

responsible treatment of antibiotic use.

The QIAstat-Dx-solutions are more than 100 different countries, including

in the US and in the states of Europe, and play a world of business

separate role in the diagnosis of Krankheiten. By the end of 2023

Weltweit installed more than 4,000 QIAstat-Dx-Systeme installed. Krankenhauser,

Labore und Kliniken estimate the QIAstat-Dx-Reihe for your einfache Handhabung

and the pure Nachweis vader verschiedener Pathogen.

QIAstat-Dx is available in two versions: QIAstat-Dx is available in four versions

Analysis module in an integrated system, with QIAstat-Dx Rise with eight

Analysis modules with a maximum duration of 160 tests at the end of the test

can.

More information about the implementation of the IVDD on the IVDR

Einschließlich eines prechenden Zeitplans finden Sie auf unserer IVDR-

Support page (https://www.qiagen.com/de-us/knowledge-and-support/product-and-

technical support/ivdr support).

More information about QIAstat-Dx can be found below

https://www.qiagen.com/applications/syndromic-testing.

Uber QIAGEN

QIAGEN NV, a Dutch holding company, is the world leader

An offer of comprehensive solutions for successful molecular recognition

from organic testing. QIAGEN’s research technology has failed

Aufreinigung und Verarbeitung von DNS, RNS und Proteinen aus Blut, Gewebe und

others Fabrics. Testing technology can examine and use these biomolecules

zur Analysis. Bioinformatic solutions and Wissensdatenbanken help

Interpretation of Daten zur Gewinnung more relevant and practically useful

Recognition. Automation solutions integrate these things and

cost-effective molecular testing workflows. QIAGEN proposes more solutions

if 500,000 can be obtained from the molecular diagnostics (Gesundheitsfürsorge)

and Life Sciences (academical research, pharmacological F&E and industrial

Anwendungen, hauptsächlich Forensik) voor Verfügung. From June 30, 2024

civilized QIAGEN weltweit more than 5,900 employees in over 35 positions.

More information about QIAGEN can be found at http://www.qiagen.com.

Forward-looking statement

One of the Angaben in die Pressemitteilung can be played in the Sin of Section 27A

the US Securities Act (US-Wertpapergesetz) from 1933 in ergänzter Fassung and

Section 21E of the US Securities Exchange Act (US-Börsengesetz) of 1934 in

ergänzter Fassung als zukunftsgerichtte Aussagen (?forward-looking statements”)

gilts. Soweit in dieser Notification zukunftsgerichttete Aussagen über QIAGENs

Products that are part of the response to the COVID-19 pandemic

Product, the Zeitplan für Marktinführungen und Entwicklungen, regulische

Genehmigungen, Financing und operative Prognosen, Wachstum, Expansionen,

Kollaborationen, Märkte, Strategie or operative Ergebnisse were authorized,

the only thing that hasn’t happened is that it’s very important for the

Cleaning Nettoumsatz and the cleansing waste Your action,

protection dies on the basis of the time Erwartungen and Annahmen, which mit

Problems may arise and risks may be taken. Dazu zählen unter

other: Risks in Zusammenhang with Wachstumsmanagement and internationally

Geschäftsaktivitäten (einschließlich Auswirkungen von Währungsschwankungen en

of the regulatory aspects of logistics processes); Schwankungen der

Betriebsergebnisse und je Verteilung auf unsere Kundengruppen; die Entwicklung

der Märkte für oursere Produkte and Kunden in der Akademischen Research, Pharma,

Extensive testing and molecular diagnosis; Changes below

Beziehungen zu Kunden, Lieferanten and strategic partners, das

Wettbewerbsumfeld, faster or unerwarteter technological walk,

Changes in the Nachfrage nach QIAGEN-Produkten (einschließlich overall

Wirtschaftlicher Entwicklungen, Höhe und Verfügbarkeit der Budgets unserer

Kunden und sonstiger Faktoren), de Möglichkeit, de regulische Zulassung

for our products that are available, there are changes in the application of QIAGENs

Products and integrated solutions and the recovery-solcher products, which

The quality of the products, new products, products and the like

of the products of the wettbewerber intend to use the wettbewerb

schützen, Marktakzeptanz new products and integration requests

Geschäfte und Technology; Maßnahmen von Regierungen; global or regional

economic economics; legal or transport clause Verzögerungen,

Natural catastrophes, political criticism or criticism in the policy of the öffentlichen

Provide reassurance and an end to the COVID-19 pandemic and

– 3 – I look at the product and other products and other

Aspekte unseres Geschäfts, oder sonstige Ereignisse höherer Gewalt; anyway dies

Effortless, that’s worth it in life with youth or

Anstehenden Acquisitionen, not wie erwartet eintritt; and other factors,

angesprochen unter ?Risikofaktoren” in current Annual Report Form 20-F.

More information can be found in Messages sent by QIAGEN outside the USA

Securities and Exchange Commission (US-Börsenaufsichtsbehörde) eingereicht hat.

Source: QIAGEN NV

Category: Business

Contact QIAGEN:

Investor Relations Public Relations

John Gilardi +49 2103 29 11711 Thomas Theuringer +49 2103 29 11826

Domenica Martorana +49 2103 29 11244 Lisa Specht +49 2103 29 14181

E-mail:

[email protected] Email: [email protected]

(mailto:[email protected] (mailto:[email protected]

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