Gradientech's Quickmic Sepsis Test System Secures Key European IVDR Certification
Gradientech's Quickmic® system, including its Quickmic® GN AST test, is now IVDR-certified and CE-marked for commercial use in the EU. This regulatory approval allows the ultra-fast antibiotic resistance test for sepsis samples to expand throughout the European market. Gradientech has achieved certification for its Quickmic® system under the European Union's In Vitro Diagnostic Regulation (IVDR). This certification covers the complete Quickmic® system, including the Quickmic® GN AST test for gram-negative bacteria and its diagnostic platform, granting it CE-marking for commercial use within the European market. According to CEO Sara Thorslund,.
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Key takeaways
- Gradientech has achieved certification for its Quickmic® system under the European Union's In Vitro Diagnostic Regulation (IVDR)
- This certification covers the complete Quickmic® system, including the Quickmic® GN AST test for gram-negative bacteria and its diagnostic platform, granting it CE-marking for commercial use within the European market
- According to CEO Sara Thorslund, this IVDR certification represents a significant commercial milestone for Gradientech
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