Diagnosis, prevention, medicine

PCR kits for diagnostics of human infectious diseases

2017-10-25

Private Joint Stock Company “Scientific Production Company “DIAPROPH-MED” announces the issuance of in vitro medical device PCR kits for diagnostics of human infectious diseases brand.

Conformity assessment according to the requirements of the Technical Regulations for medical products for in vitro diagnostics, approved by Resolution of the Cabinet of Ministers of Ukraine of 02.10.2013 . No. 754 is conducted by Conformity assessment Body SE “Ukrmetrteststandard” (ID No. UA.TR.001, Accreditation Certificate No 1023).

Conformity Assessment Body SE “Ukrmetrteststandard” certifies that:

- in vitro medical device PCR kits for diagnostics of human infectious diseases brand manufactured by PJSC “SPC “DIAPROPH-MED” meets the requirements of the Technical Regulations for medical products for in vitro diagnostics, approved by Resolution of the Cabinet of Ministers of Ukraine of 02.10.2013 . No. 754 .

Conformity assessment route followed is Annex IV of Technical Regulations for medical products for in vitro diagnostics (including design examination).

Certificate No. UA.TR.001.014832-17 in the Register of accredited CABs. Valid from October 24, 2017. Valid until October 23, 2022.

- design of in vitro medical device PCR kits for diagnostics of human infectious diseases brand manufactured by PJSC “SPC “DIAPROPH-MED” meets the requirements of Annex I of Technical Regulations for medical products for in vitro diagnostics, approved by Resolution of the Cabinet of Ministers of Ukraine of 02.10.2013 . No. 754 with considering of intended use of the device.

Certificate No UA.TR.001.014816-17 in the Register of accredited CABs. Valid from October 20, 2017. Valid until October 19, 2022.