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/IVD/2019/000211_d2f0d5c8b411551cf71a303567db00ea_b934aec9b3a12c6d4d451ddc15b08f53. This device is marketed under the brand name Actim Prom. The license holder is Advy Chemical Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Qualitative test for detection of Amniotic fluid in vaginal secretion

UID: IMP/IVD/2019/000211_d2f0d5c8b411551cf71a303567db00ea_b934aec9b3a12c6d4d451ddc15b08f53

Brand Name

Actim Prom

License Holder

Advy Chemical Private Limited

Device Class

Class B

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) in pregnant women