ROM Plus®, Fetal Membranes Rupture Test

Device typeAmniotic fluid leak detection device IVD: An in vitro diagnostic device designed to help identify amniotic fluid in the vaginal secretions of a pregnant woman to confirm membrane rupture (normal or premature). The device typically involves a colour indicator that signals within the pH range of amniotic fluid (above 6.5) after contact. The device may consist of a panty liner with attached indicator strip, or a nitrazine-impregnated swab or paper. The device may be used in the home or in a clinical setting. This is a single-use device.

FDA categoryImmunoassay For Detection Of Amniotic Fluid Protein(S).

Device ID00814247020406

AvailabilityPrescription

Single useYes

SterileYes

LatexNot made with natural rubber latex

MRI safetyLabeling does not contain MRI Safety Information