Quality is primary asset for TURKLAB since its establishment date. We have reached many milestones at quality and certification as some remarks given below;

Turklab is certified and approved by many well-known authorities in the past. Some examples,

  • TÜV Product Service GmbH (2001)
  • MDC – Germany (2007)
  • PCBC- Poland (Since 2008)

Also Turklab has managed to be first in the world for;

  • First company in the world to have CE certification for in-vitro diagnostics industry from Notified Body (TUV PRODUCT SERVICE-0123) at Munich (01.25.2001)

First Company in the world to have CE certification for; HIV, HCV, HBsAg and Anti-HBs tests all together  according to 98/79/EC Directive by PCBC-1434 Polish Notified Body (2008)

 

Türklab is certified for

  • Certified for ISO 9001
  • Certified for ISO 13485
  • Accordance with GMP

Türklab products are certified for;

  • CE certification for Anti-HIV, Anti-HCV, HBsAg and Anti-HBs tests according to  EC/98/79 Annex II – List A
    (Full Quality Certificate, Design Examination Certificate, Batch Verification Certificate)
  • CE certificare for OTC products, hCG
  • FDA approval for OTC products, hCG
  • WHO prequalification of HIV test is on progress

Approval and Registration of our products;

  • Approved by Turkish MoH, UBB database,
  • Registered its products in Europe Medical Device System
  • Saudi FDA
  • Iran MoH
  • ANVISA-Brazil
  • Ekvator  - Ministerio de Salud Pública
  • ...