AmniSure ROM Test - Qualitative PAMG-1 kit, for detecting amniotic fluid - Vietnam Registration 230001580/PCBB-HCM
Access comprehensive regulatory information for AmniSure ROM Test - Qualitative PAMG-1 kit, for detecting amniotic fluid in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 230001580/PCBB-HCM and manufactured by QIAGEN Sciences LLC.
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Device Details
Registration Details
230001580/PCBB-HCM
000.00.19.H29-230713-0001
AmniSure® ROM Test
FMRT-1-10-ML-RT; FMRT-1-25-ML-RT
Technical Details
AmniSure ROM Test is a qualitative, rapid immunoassay test for the detection of amniotic fluid in the vaginal secretions of pregnant women. The test is used by healthcare professionals to support the diagnosis of premature rupture of membranes in pregnant women.
Dates and Status
Jul 24, 2023