Qualitative test for detection of Amniotic fluid in vaginal secretion - India CDSCO Medical Device Registration
Qualitative test for detection of Amniotic fluid in vaginal secretion is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000222_d2f0d5c8b411551cf71a303567db00ea_a62b63f9952a62a847cfc494cad6b408. This device is marketed under the brand name Actim Prom Kit. The license holder is Bharat Serums And Vaccines Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
Actim Prom Kit
License Holder
Bharat Serums And Vaccines LimitedDevice Class
Approving Authority
CDSCO
Product Information
Actim PROM test 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 (Actim Prom Kit) in pregnant women.
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