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We’re excited to announce that OGT’s haematology and prenatal CytoCell FISH probes have been granted IVDR certification!
- Proven safe, reliable and effective probes
- Essential for haematological malignancies and aneuploidy testing
- Clinical labs will be required to use an
- IVDR-certified probe if one is available on the market
- No revalidation needed for existing users of
- an IVDD equivalent probe
Why choose OGT’s CytoCell probes?
In 1991, became the first provider of FISH probes in the world. Over 30 years later, OGT is the first to- market with their In Vitro Diagnostic Regulation (IVDR) certified FISH Probes important for the management of haematological malignancies and aneuploidy testing! IVDR is a priority for OGT as it ensures safe, reliable and effective products for you and your patients.
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Quality and confidence
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No revalidation needed
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IVDR certification demonstrates OGT’s continued commitment to provide safe, reliable and effective products. |
IVDR Cytocell probes are the same robust, reliable designs, so existing users do not have to revalidate, saving you time in the lab. |
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Support
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Clinical expertise |
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OGT’s experienced Field Applications Scientists are dedicated to supporting you to optimise products, on-site or remotely. |
OGT has more than 100 years of clinical experience within the company, helping to develop FISH probes that are IVDR compliant |
Introducing the IVDR-Certified FISH Probes
Regulation (EU) 2017/746 (IVDR) is a new regulatory framework for IVD medical devices. It sets higher standards for quality and safety for in vitro diagnostic medical devices to ensure the highest level of public health protection. All CytoCell® IVD FISH probes are affected by the IVDR and need to be compliant by May 2026. Probes used for Research Use Only (RUO) are unaffected. Critically, clinical labs will be required to use an IVDR-certified probe if one is available on the market by this date. OGT will continue to pursue additional certification for CytoCell FISH probe portfolio.
Watch the video to learn more!
