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Amniotic fluid leak detection device

Definition
A 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
11
Last updated
2019-03-30 12:04:12

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00814247020406ROM Plus®, Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCROM-10252016-09-01
00814247020864ROM Plus, Complete Kit Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCROM-70252016-09-23
10814247020434ROM Plus®, Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCROM-50252016-09-01
10814247020854ROM Plus, Quality Control for Fetal Membranes Rupture TesCLINICAL INNOVATIONS, LLCROM-60252016-09-23
10814247020892ROM Plus, Complete Kit Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCROM-70652016-09-23
10814247020922ROM Plus, Complete Kit Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCROM-70552016-09-23
10814247020953ROM Plus, Complete Kit Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCROM-30252016-09-23
20814247020424ROM Plus®, Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCROM-50002016-09-01
20814247020448ROM Plus®, Fetal Membranes Rupture Collection KitCLINICAL INNOVATIONS, LLCROM-60002016-09-01
20814247020455ROM Plus® Quality Control KitCLINICAL INNOVATIONS, LLCROM-QC2016-09-01
20814247020462ROM Plus® Strip Quality ControlCLINICAL INNOVATIONS, LLCROM-QCS2016-09-01