Test strip, pregnancy

Type of medical device or related product
General vs. specific use (health condition)
Intended population sex
Level of technical knowledge
Capital
Reusable
Requirements
None
EMDN related code(s)
W01021603
FERTILITY / PREGNANCY RT & POC
GMDN related code(s)
65241
Multiple 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.)