Frida

Device typeTotal human chorionic gonadotropin IVD, kit, rapid ICT, self-testing: A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment to detect pregnancy.

FDA categoryKit, Test, Pregnancy, Hcg, Over The Counter

Device ID10810028774084

Single useYes

MRI safetyLabeling does not contain MRI Safety Information