醫療器材認證

The One InstantCare Chromogenic Rapid Screening Analyzer

許可證

通過台灣衛福部第一等級醫療器材許可證




美國FDA認證

神光快篩檢驗儀通過美國FDA認證


Colorimeter, Photometer, Spectrophotometer For Clinical Use –
The ONE InstantCare Chromogenic Rapid Screening Analyzer

FDA 510(K) Reg. No. 3017810861
Owner Number in FDA: 10078261
Listing number in FDA: D422000
Registration number in FDA: 3017810861