QIAGEN N.V.

QMS Certificates (Quality Management System)

• ISO 9001
• ISO 13485

QIAGEN GmbH

QMS Certificates (Quality Management System)

• ISO 9001
• ISO 13485
• ISO 18385
• Medical Device Single Audit Program (MDSAP)

EU Quality Management System Certificate (IVDR) – Regulation EU 2017 / 746
on In Diagnostic Medical Devices (Annex IX chapter I, Section 2 and 3 and Chapter III)

• ipsogen JAK2 RGQ PCR Kit

EC Design Examination Certificate - EC Directive 98/79/EC Annex IV -Article 4

• artus-HIV-1 RG RT-PCR Kit
• artus-HIV-1-QS-RGQ Kit
• artus-HCV RG RT-PCR Kit
• artus-HCV QS RGQ-PCR Kit
• artus-HBV RG PCR Kit
• artus HBV QS RGQ Kit

Approval EC Directive 98/79/EC Annex IV - Article 3 - Full Quality Assurance
System In vitro diagnostic medical devices

• PCR reagents for the detection of Chlamydia trachomatis and Chlamydophila pneumoniae
• PCR reagents for the detection of Cytomegaloviruses
• PCR reagents for the detection of Hepatitis B
• PCR reagents for the detection of Hepatitis C
• PCR reagents for the detection of HI Viruses

Medical Device License Health Canada

• QIASYMPHONY DSP HPV Media Kit

QIAGEN Sciences LLC.

QMS Certificates (Quality Management System)

• ISO 9001
• ISO 13485
• Medical Device Single Audit Program (MDSAP)

Approval EC Directive 98/79/EC Annex IV - Article 3 - Full Quality Assurance
System In vitro diagnostic medical devices

• Hybrid Capture 2 CT-ID DNA Test

Approval EC Directive 93/42/EEC Annex V - Article 3 - Quality Assurance
Production

• Hybrid Capture Femal Swab Specimen Collection

DIALUNOX GmbH

QMS Certificates (Quality Management System)

• ISO 9001 
• ISO 13485

QIAGEN Manchester Ltd.

QMS Certificates (Quality Management System)

• ISO 9001
• ISO 13485
• Medical Device Single Audit Program (MDSAP)

Scandinavian Gene Synthesis AB

QMS Certificates (Quality Management System)

• ISO 9001
• ISO 13485

QIAGEN Pty Ltd.

QMS Certificates (Quality Management System)

• ISO 9001

QIAGEN Shenzhen Co. Ltd.

QMS Certificates (Quality Management System)

• ISO 13485
• ISO 18385

TIANGEN Biotech (Beijing) Co., Ltd.

QMS Certificates (Quality Management System)

• ISO 9001

QIAGEN Singapure PTE Ltd.

QMS Certificates (Quality Management System)

• Good Distribution Practice

QIAGEN Biotech Malaysia Sdn Bhd.

QMS Certificates (Quality Management System)

• Good Distribution Practice

QIAGEN Frederick

QMS Certificates (Quality Management System)

• ISO 9001

QIAGEN Redwood City

QMS Certificates (Quality Management System)

• ISO 9001

QIAGEN Aarhus A/S

QMS Certificates (Quality Management System)

• ISO 9001
• ISO 13485

QIAGEN Beverly Inc.

QMS Certificates (Quality Management System)

• ISO 13485

QIAGEN S.R.l.

QMS Certificates (Quality Management System)

• ISO 9001
• ISO 13485

STAT Dx Life S.L

QMS Certificates (Quality Management System)

• ISO 13485
• Medical Device Single Audit Program (MDSAP)

QIAGEN Business Services Sp. T. o.o 

QMS Certificates (Quality Management System)

• ISO 13485