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 ID00850042559833
AvailabilityOver the counter
Single useYes
LatexNot made with natural rubber latex
MRI safetyLabeling does not contain MRI Safety Information