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Immunohistochimie
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INSTRUMENT
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MOLÉCULAIRE
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HISTOLOGIE
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CYTOLOGIE
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Pathologie numérique
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Solution
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FDA approval
2025-06-02Celnovte Biotechnology proudly announces that our comprehensive range of immunohistochemistry (IHC) products has officially achieved FDA certification, a significant milestone reinforcing our commitment to delivering high-quality, reliable solutions for pathology and cancer diagnostics in the United States.
Our FDA-marked IHC product portfolio encompasses primary antibodies, advanced detection systems, and fully automated stainers, meticulously engineered to meet the stringent quality and safety standards set by the FDA. This certification validates our unwavering commitment to regulatory compliance and ensures our IHC products align with the rigorous In Vitro Diagnostic Regulation (IVDR) requirements.
With over 15 years of expertise in the IVD industry and a strong global footprint, Celnovte continues to provide state-of-the-art technology that enhances diagnostic accuracy and supports precision medicine. Our FDA-certified IHC products undergo stringent quality control and performance validation, delivering exceptional reliability and workflow efficiency for clinical laboratories.
By securing the FDA mark, Celnovte reaffirms its position as a trusted partner in the global pathology market. We are dedicated to supporting healthcare professionals and laboratories in delivering superior diagnostic services. Discover how our FDA-certified IHC solutions can elevate your laboratory’s capabilities today.
✅ Explore our FDA-marked IHC solutions now and unlock new possibilities for pathology excellence.
Check on FDA official website: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
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