Devices

AmniSure

  • Model / Serial
    Lot Number/ Exp. Date  A7003, 01/2009. A7002, 11/2008,  A7001, 10/2008, A6005, 04/2008,  A6004, 01/2008, A6003, 09/2007, and  A6002-3, 09/2007
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide, USA, Australia, Austria, Italy, Korea, Bulgaria, Russia, Spain, Kuwait, Switzerland, Luexemburg, Ireland, Denmark, Netherlands, Jordan, Israel, Chile, UK, Singapore, Basil, New Zealand, Turkey, France, Greece, and Equador
  • Product Description
    AmniSure ROM Test, Fetal Membrane Rupture Test for || In-Vitro Diagnostic Use, Model: FMRT-1, AmniSure International LLC, Cambridge, MA 02138
  • Manufacturer
    AmniSure International LLC
  • 1 Event

Manufacturer

AmniSure International LLC
  • Manufacturer Address
    AmniSure International LLC, 31 Sacramento St # 5, Cambridge MA 02138-1820
  • Manufacturer Parent Company (2017)
    QIAGEN N.V.
  • Source
    USFDA