Rapid Dipstick Test for Detection of IGFBP-1 as Indicator of Premature Rupture of Amniotic Fluid Membrane - India CDSCO Medical Device Registration
Rapid Dipstick Test for Detection of IGFBP-1 as Indicator of Premature Rupture of Amniotic Fluid Membrane is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000208_3264cb10a5855042d3cc592022afcbe9_9d6492026086898dad49555d8ee41e1f. This device is marketed under the brand name EzDx Actim Partus . The license holder is ADVY CHEMICAL PVT. LTD., and it is classified as Device Class Class B. The approving authority is Kokan Division.
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Brand Name
EzDx Actim Partus
License Holder
ADVY CHEMICAL PVT. LTD.Device Class
Approving Authority
Kokan Division
Product Information
The Rapid Dipstick Test for Detection of IGFBP-1 as Indicator of Premature Rupture of Amniotic Fluid Membrane is a visually interpreted, qualitative immunochromatographic dipstick test for detection of amniotic fluid in vaginal secretions during pregnancy. Actim PROM detects IGFBP-1, which is a major protein in amniotic fluid and a marker of the amniotic fluid in a vaginal sample. The test is intended for professional use to help diagnose the rupture of fetal membranes (EzDx Actim Partus ) in pregnant women.
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