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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)
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 TM 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 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
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  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

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  QIAGEN Lake Constance GmbH QMS Certificates (Quality Management System) 
  ISO 9001   ISO 13485
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  QIAGEN Manchester Ltd. QMS Certificates (Quality Management System)    ISO 9001   ISO 13485
  Medical Device Single Audit Program (MDSAP)
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  Scandinavian Gene Synthesis AB QMS Certificates (Quality Management System)   ISO 9001
  ISO 13485

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  QIAGEN Pty Ltd. QMS Certificates (Quality Management System)   ISO 9001
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QIAGEN Shenzhen Co. Ltd. QMS Certificates (Quality Management System) ISO 13485 __________________________________________________________________________________________________

  TIANGEN Biotech (Beijing) Co., Ltd. QMS Certificates (Quality Management System)    ISO 9001
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  QIAGEN Singapure PTE Ltd. QMS Certificates (Quality Management System)    Good Distribution Practice
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  QIAGEN Biotech Malaysia Sdn Bhd. QMS Certificates (Quality Management System)
  Good Distribution Practice
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  QIAGEN Frederick QMS Certificates (Quality Management System)   ISO 9001
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  QIAGEN Redwood City QMS Certificates (Quality Management System)   ISO 9001
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  QIAGEN Sciences LLC (Waltham)  QMS Certificates (Quality Management System)   ISO 13485
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  QIAGEN Aarhus A/S QMS Certificates (Quality Management System)   ISO 9001
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  QIAGEN Beverly Inc. QMS Certificates (Quality Management System)   ISO 13485
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  QIAGEN S.R.l. QMS Certificates (Quality Management System)  ISO 9001
 ISO 13485
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  STAT Dx Life S.L QMS Certificates (Quality Management System)    ISO 13485