Vietnam MOH registration 230001580/PCBB-HCM

AmniSure ROM Test - Qualitative PAMG-1 kit, for detecting amniotic fluid

VN: AmniSure ROM Test - Bộ kit xét nghiệm định tính PAMG-1, phát hiện ối rỉ

AmniSure® ROM Test

Vietnam·Risk Class TTBYT Loại B·AmniSure® ROM Test·QIAGEN Sciences LLC·Registered Jul 24, 2023

Registration details

Analysis ID: 230001580/PCBB-HCM
Submission ID: 000.00.19.H29-230713-0001
Product Type: AmniSure® ROM Test
Product Code: FMRT-1-10-ML-RT; FMRT-1-25-ML-RT

Company information

Manufacturer: QIAGEN Sciences LLC

Technical details

Intended Use: 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

Registration Date: Jul 24, 2023

About this record

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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