Amniocentesis kit, medicated, single-use

An amniocentesis kit, medicated, single-use is a sterile collection system designed to withdraw amniotic fluid through the abdominal wall for laboratory analysis. It typically contains a needle with a stylet, a syringe, specimen containers with transport medium, drapes, dressings, and the necessary pharmaceuticals, and is used primarily between 16 and 18 weeks of pregnancy for diagnosing congenital conditions or later in pregnancy to assess fetal maturity.

These kits are supplied as disposable, single-use devices and are regulated as medical devices that combine a sampling instrument with associated drugs. Manufacturers must ensure sterility, proper labeling, and compliance with the applicable medical device regulations for combination products in each market.