TURKLAB TIBBI MALZEMELER SANAYI VE TICARET ANONIM SIRKETI
Company Details
Company Introduction
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 2000s 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, "Gokhan Laboratories" in diagnostic field and successfully adapted its product line through its own.Presently, the product line is expanded. 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 Izmir 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,1. TUV Product Service GmbH (2001)2. MDC Germany (2007)3. 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)Turklab is certified for1. ISO 90012. ISO 134853. GMPTurklab products are certified for;1. 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)2. CE certification for OTC products, hCG3. FDA approval for OTC products, hCG4. WHO prequalification of HIV test is on progress
Company Information
Company Product
- SYPHILIS (Anti-TP) TESTGONORRHEA TESTStrong Adhesive Surface ECG ElectrodesCE MARKED ANTI-HCV RAPID TESTCE MARKED ANTI-HIV 1/2 RAPID TESTCE MARKED HBsAg RAPID TESTCE MARKED ANTI-HBs (HBsAb) RAPID TESTH.PYLORI ANTIGEN TESTFast, Accurate, Precise Pregnancy (HCG) Cassette Test with CE and FDACE MARKED ANTI-HIV 1/2 RAPID TESTCE MARKED ANTI-HIV 1/2 RAPID TESTCE MARKED ANTI-HIV 1/2 RAPID TESTONE STEP MALARIA RAPID TESTDENGUE RAPID TEST KITRAPID FOB TESTHOT SALES BABY NAPPY-DIAPER RASH CREAM , NEW FORMULAH.PYLORI ANTIGEN RAPID TESTSTREP A THROAT SWAB RAPID TEST KITCE MARKED HBsAg RAPID TESTCE MARKED HBsAg RAPID TESTFast, Accurate, Precise Pregnancy (HCG) Cassette Test with CE and FDACE MARKED ANTI-HCV RAPID TESTCE MARKED ANTI-HCV RAPID TESTCE MARKED ANTI-HCV RAPID TESTHCG Urine Easy Pregnancy Test Midstream CE MARKEDADULT, PEDIATRIC, EFORT ECG ElectrodesTROPONIN I RAPID TESTFOB Rapid Diagnostic Feces Test Kit/ Fecal Occult Blood TestRAPID FOB TEST KIT/TUMOR MARKERCK-MB CARDIAC TESTHIV Test Kit with CE 1434 Marked