Turklab Tibbi Malzemeler San. Tic. A.S.

In 1996 Turklab is established as the first and only “Diagnostic Test Manufacturer” of Turkey.
The story of production started with only pregnancy test in the beginning but in meantime the
researches and experience of Turklab is been developed and the new product lines has been added
to its product line accordingly. In this period Turklab has managed to achieve first CE certificate for
home-use pregnancy test in the World.
Accordingly Ovulation and Menopause tests are adapted in manufacturing line and their CE
certificates are achieved, and In early 2000’s infectious disease tests such as HIV and Hepatitis are
also successfully included in product portfolio.
In 2008 Turklab achieved its CE mark for Anti-HIV, Anti-HCV, HBsAg and HBsAb test as the first
company in the World achieving such a success.
In 2010 Turklab purchased another Turkish company, “Gökhan Laboratories” in diagnostic field and
succesfully adapted its product line through its own.
Presently , the product line is expanded with other Infectious Disease tests, Tumor Markers, Cardiac
Markers, STDs and Antibiotics susceptibility tests.
In 2015 Turklab renewed its image by the change of Logo and corporate ID as well as moving
production site to its own facilities in Izmır ITOB Industrial Zone.

~~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)
• Paul Ehrlich Institut (2007)
• PCBC- Poland (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 certification for Chlamydia Test
• CE certification for PSA – semi quantitative test,
• CE certificare for OTC products, hCG, LH, FSH, FOB