This molecular diagnostic PCR kit is CE approved and complies with the Directive 98/79/EC for IVD, in vitro PCR Diagnostics. The PCR kit is ISO 9001:2008 and ISO 13485:2012, CE marked with the in vitro diagnostic medical divices requirements Annex 2 of list B of the laboratory Directive 98/79/EC and can be used for diagnosis of viruses. The kit inculde all reagents for PCR or RT-PCR of viral DNA or RNA.
This HPV High Risk Screen Real-TM Quant Real Time Test with silica DNA extraction kit (2 optical channels) is used as PCR kit for molecular diagnostics with elecrtophoresis, qPCR or real-time PCR of 100 Tests per screening.