DeviceClearance

Product code NQM— Clinical Chemistry

AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1

Classification name
Immunoassay For Detection Of Amniotic Fluid Protein(S).
Device class
Class 1
Regulation
21 CFR 862.1550
Advisory panel
Clinical Chemistry
Total cleared
2
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code NQM under 21 CFR 862.1550, via openFDA

Market context for product code NQM

FDA has cleared 2 devices under product code NQM between 2009 and 2011, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code NQM

Recent clearances under product code NQM

Data sourced from openFDA. This site is unofficial and independent of the FDA.