VALIDATION OF TICKPLEX

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TICKPLEX is the outcome of a research project funded by the Finnish Funding Agency for Technology and Innovation (now Business Finland) from July 2015 to Sept 2016. Scientific and clinical validation for TICKPLEX BASIC AND PLUS kits follows applicable laws such as,

  • The EU IVD Directive (in vitro diagnostic medical devices directive) 98/79/EC, and

  • The Finnish Medical Device Law Regarding Healthcare, Devices and Supplies (629/2010) for IVD CE conformity declaration

 

Therefore, the TICKPLEX test conforms to the following harmonized standards,

  • SFS-EN ISO 14971 Medical devices. Application of risk management to medical devices

  • SFS-EN 13612n + AC Performance evaluation of in vitro diagnostic medical devices

  • SFS-EN ISO 23640 In vitro diagnostic medical devices. Evaluation of the stability of in vitro medical reagents

  • SFS-EN ISO 18113-1 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 1: terms, definitions and general requirements.

  • SFS-EN-ISO 18113-2. Part 1: terms, definitions and general requirements.

  • SFS-EN 15223-1:2016 Medical devices. Symbols to use with medical device label, labelling, and information supplied. Part 1: General requirements

 

The test kit is registered with the national regulatory authorities here in Finland as ascribed by the law. Also, Te?ted Oy is ISO 13485:2016 accredited to manufacture TICKPLEX in Finland. Following the EU IVD Directive 98/79/EC, clinical laboratories with or without an ISO 15189 accreditation should validate TICKPLEX before any clinical or commercial use. TICKPLEX is a CE and IVD test with successful and independent validation by clinical labs in Germany, Poland, Netherlands, Spain, Latvia, Ireland, USA, Mexico, and Finland. Hence, the TICKPLEX test is scientifically, clinically and independently validated as per industry standards, good scientific practices and EU law. You may download our ISO 13485:2016 certificate, peer-review publication, and instructions for use in the link below.