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510(k) Data Aggregation
K Number
K081767Device Name
AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1
Manufacturer
AMNISURE INTERNATIONAL, LLC
Date Cleared
2009-01-09
(203 days)
Product Code
NQM, NOM
Regulation Number
862.1550Why did this record match?
Applicant Name (Manufacturer) :
AMNISURE INTERNATIONAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Amnisure® ROM (rupture of fetal membrane) Test is a rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of ammiotic fluid in vaginal secretion of pregnant women. Amnisure® detects PAMG-1 protein marker of the amnictic fluid in vaginal secretions. The test is for use by health care professionals to aid in the detection of ROM when patients report signs, symptoms or complaints suggestive of ROM.
Device Description
The Amnisure® ROM (rupture of fetal membrane) Test is a rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of ammiotic fluid in vaginal secretion of pregnant women. Amnisure® detects PAMG-1 protein marker of the amnictic fluid in vaginal secretions.
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