IVD equipment ISO 13485:2016 EN ISO 13485:2016 (SGS) Certificate (TW18/10421)

2023-11-28
■The management system of CHROMA ATE INC. has been assessed and certified as meeting the requirements of
●ISO 13485:2016
●EN ISO 13485:2016
■For the following activities
●Design and manufacture of IVD equipment for PCR/qPCR amplification, fluorescence detection, and nucleic acids hybridization.
●Design and manufacture of IVD equipment for nuceic acid purification and microtiter diluting and dispensing.

CHROMA

IVD equipment

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Test Report

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English Chinese Chinese and English Japanese

05 October 2023

Issue 5

TW18/10421

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