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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EMERGO, Our Authorized Rep in Europe

Authorized Representative:

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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