FDA-Device2018-08-15Class I
AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women.
Qiagen Sciences, Inc.
Hazard
Potential for control line not appearing on the test strip
Sold states
Worldwide - US Nationwide distribution an in the country of , Canada
Affected count
1620 kits
Manufactured in
19300 Germantown Rd, N/A, Germantown, MD, United States
Products
AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2577-2018Don't want to check this manually?
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