Amniotic fluid leak detection device IVD

Definition
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.
GUDID devices
12
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00814247020420ROM Plus®, Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCROM-50002016-09-01
00814247020437ROM Plus®, Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCROM-50252016-09-01
00814247020444ROM Plus®, Fetal Membranes Rupture Collection KitCLINICAL INNOVATIONS, LLCROM-60002016-09-01
00814247020451ROM Plus® Quality Control KitCLINICAL INNOVATIONS, LLCROM-QC2016-09-01
00814247020468ROM Plus® Strip Quality ControlCLINICAL INNOVATIONS, LLCROM-QCS2016-09-01
00814247020857ROM Plus, Quality Control for Fetal Membranes Rupture TesCLINICAL INNOVATIONS, LLCROM-60252016-09-23
00814247020895ROM Plus, Complete Kit Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCROM-70652016-09-23
00814247020925ROM Plus, Complete Kit Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCROM-70552016-09-23
00814247020956ROM Plus, Complete Kit Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCROM-30252016-09-23
05060259071300AmnicatorsMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDN/a2023-10-05
05060259071317AmnicatorsMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDN/a2023-10-05
25060259071304AmnicatorsMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDN/a2023-10-05