Vietnam MOH registration 240000034/PCBA-HCM

IVD preparation of the sample for the extraction of nucleic acid

VN: IVD chuẩn bị mẫu để chiết tách acid nucleic

Vietnam·Risk Class TTBYT Loại A·cobas® Specimen Pre-Extraction Reagent·Roche Molecular Systems, Inc.·Registered Jan 04, 2024

Registration details

Analysis ID: 240000034/PCBA-HCM
Submission ID: 000.00.19.H29-231229-0012
Product Type: cobas® Specimen Pre-Extraction Reagent
Product Code: 08261601190

Company information

Manufacturer: Roche Molecular Systems, Inc.
Manufacturer Country: UNITED STATES
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: cobas® Specimen Pre-Extraction Reagent is used with the cobas® prime pre-analysis system.

Dates and status

Registration Date: Jan 04, 2024

About this record

Access comprehensive regulatory information for IVD preparation of the sample for the extraction of nucleic acid in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại A medical device is registered under number 240000034/PCBA-HCM and manufactured by Roche Molecular Systems, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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