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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.
Monoclonals are usually produced in mouse as host species and polyclonals in rabbit or goat. Multi species reactivity is achieved by selecting consensus epitopes when blasting the gene for a reactive, innugenic epitope that is the same in the different target species.
This Ureaplasma species Real-TM Real Time Test with silica DNA extraction kit is used as PCR kit for molecular diagnostics with elecrtophoresis, qPCR or real-time PCR of 100 Tests per screening.