Amazewell

Device typeMultiple female fertility marker IVD, kit, rapid ICT, clinical: A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of a combination of different types of female fertility markers [e.g., estrone-3-glucuronide (E1-3G), pregnanediol-3-glucuronide (PdG), luteinizing hormone (LH) and 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 used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

FDA categoryImmunoassay, Pregnanediol Glucuronide, Over The Counter

Device ID00850054867469

AvailabilityOver the counter

Single useYes

MRI safetyLabeling does not contain MRI Safety Information