FDA Product Code NQM: Immunoassay For Detection Of Amniotic Fluid Protein(s).
The Test Is For Use By Health Care Professionals To Aid In The Detection Of Fetal Membrane Rupture In Pregnant Women, When They Report Signs, Symptoms Or Complaints Suggestive Of Such Rupture.
Leading manufacturers include Amnisure International, LLC and Clinical Innovations, LLC.
2
Total
2
Cleared
235d
Avg days
2009
Since
FDA 510(k) Cleared Immunoassay For Detection Of Amniotic Fluid Protein(s). Devices (Product Code NQM)
2 devices
Cleared
Nov 23, 2011
ROM PLUS
Clinical Innovations, LLC
Chemistry
266d
Cleared
Jan 09, 2009
AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1
Amnisure International, LLC
Chemistry
203d