Pregmate

Device typeFollicle stimulating hormone (FSH) 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 follicle stimulating hormone (FSH) 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 as an aid in the diagnosis of conditions related to reproductive health (e.g., menopause, infertility).

FDA categoryTest, Follicle Stimulating Hormone (Fsh), Over The Counter

Device ID00850081966005

AvailabilityOver the counter

Single useYes

MRI safetyLabeling does not contain MRI Safety Information