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History
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  • Apr. 2020Two POCT registration certificates (including β-hCG, ACR) were obtained, having 14 POCT projects
  • Nov. 2019Registration certificates of LP-100 dry chemical analyzer and blood lipid detection card were obtained
  • Jul. 2019Having a strategic partnership with China Resources Pharmaceutical Group Limited
  • Jul. 2019Three POCT registration certificates (including cTnl/CK-MB/MYO, PGI/PGII, SAA) were obtained, having 11 POCT projects
  • Dec. 2018LTRIC-600 time-resolved fluorescence immunoassay analyzer was shortlisted in "Innovative Medical Device Product Catalog of Ministry of Science and Technology"
  • Feb. 2016Registration certificate of handheld instrument PocRoc 2S was obtained
  • Agu. 2015Four POCT registration certificates (including CRP, PCT, H-FABP, D-Dimer) was obtained, having eight POCT projects
  • Jul. 2015CE certification was obtained
  • Mar. 2014CFDA approvals for five immunoassay reagents adaptable to most chemical analyzers were obtained
  • Feb. 2014CFDA approvals for time-resolved fluorescence immunochromatographic analyzer were obtained
  • Sep. 2013Lumigenex passed The first Food and Drug Administration by the Suzhou Municipal Quality Management System Assessment
  • Aug. 2013Lumigenex was establishment of a strategic partnership with Haitong Group
  • Apr. 2013Lumigenex was granted a "CFDA Medical Device Manufacturing Enterprise License"
  • Feb. 2010The company was incorporated
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Earlier
Mar. 2014

CFDA approvals for five immunoassay reagents adaptable to most chemical analyzers were obtained

Feb. 2014

CFDA approvals for time-resolved fluorescence immunochromatographic analyzer were obtained

Sep. 2013

Lumigenex passed The first Food and Drug Administration by the Suzhou Municipal Quality Management System Assessment