Certificates and Registrations

Novodiax continues to rapidly develop and deliver safe, effective and reliable products for In Vitro Diagnostic (IVD) use!  Please see our relevant certificates and registrations below for US and international distribution.

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Certificate of IVD / cGMP manufacturing

Our IVD Test Menu Continues to Grow

Novodiax ihcDirect® family of products FDA Listed:

AE1/AE3, Calponin, CEA, CD20, CD45, CK5, CK7, CK 8/18, CK19, CK20, Pan-CK 4Abs, EMA, GFAP, Ki67, Mart-1, Podoplanin, SMMHC, and Vimentin.


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Registration: ISO 13485:2016

Our Continued Focus Upon Quality:

Novodiax continues to adapt and improve our Quality Systems to cover a wider range of products including instrument systems.

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Device Manufacturing License

California Department of Public Health: Food and Drug Branch

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become A distributor

Contact: marketing@novodiax.com


See our Distributors Page