Today marks exactly one year since we have sold the first DryFlowEx PNH High-Sensitivity Assay Kit! And roughly 2.5 years since the launch of the new generation of our TBNK phenotyping reagents! All the mentioned reagents have been already developed in accordance with current requirements of the IVDR and are registered in EU countries, but also in a range of other countries, such as Switzerland, Great Britain, UAE, Peru... Despite of this fact, until recently we lacked ability to satisfy all our customers demands - in some countries (Australia, USA, Brazil) we had no opportunity to register these diagnostics for technical, administrative or capacity reasons. And so, to meet the request of our customers also from these countries, we have supplemented the EXBIO products suite with the RUO version of the above sets. We’re happy to present an overview of the RUO versions of the PNH and TBNK EXBIO diagnostic kits:
CE IVD Cat. No.:
CE IVD Product title:
RUO alternative Cat. No.:
RUO alternative Product title:
ED7750
DryFlowEx PNH High-Sensitivity Assay Kit
ED7787
DryFlowEx PNH High-Sensitivity Assay Kit (RUO)
ED7733
KOMBITEST TBNK 6-color
ED7766
KOMBITEST TBNK 6-color (RUO)
ED7734
KOMBITEST T Cell 4-color
ED7781
KOMBITEST T Cell 4-color (RUO)
ED7735
KOMBITEST B/NK Cell 4-color
ED7782
KOMBITEST B/NK Cell 4-color (RUO)
ED7736
DryFlowEx TBNK 6-color
ED7789
DryFlowEx TBNK 6-color (RUO)
Would you like to know how the above-mentioned EXBIO kits could be ordered? Check out our list of Authorized distributors on the EXBIO website here, or reach out us directly at info@exbio.cz, we are happy to provide you the relevant distributor contact, advise you on the choice of reagents and answer any other questions you may have.
IMPORTANT REGULATORY NOTE: Products intended for Research-Use-Only (RUO) are not intended for diagnostic purposes and thus do not have a stated intended purpose for use in a specific diagnostic test. Some EXBIO RUO kits are derived from IVD medical devices by changing the catalog number, labeling and instruction for use and are available in countries where these IVD medical devices are not yet registered. These RUO kits can be used by the clinical laboratory for diagnostic test provided that local regulatory requirements for the laboratory developed test are met. Thus, if the clinical laboratory uses the RUO kit for diagnostic purposes, it is responsible for the clinical validity of the results obtained.
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