Vietnam MOH registration 240001096/PCBA-HN

IVD for enzymatic digestion, used for the extraction of nucleic acids

VN: IVD đệm ly giải dùng để tách chiết acid nucleic
Vietnam flagVietnam·Risk Class TTBYT Loại A·Theo theo phụ lục·NeuMoDx Molecular, Inc.·Registered Jun 06, 2024
Registration details
Analysis ID
240001096/PCBA-HN
Submission ID
000.00.19.H26-240507-0012
Product Type
Theo theo phụ lục
Product Code
Theo phụ lục
Company information
Manufacturer Country
Theo theo phụ lục
Product Owner
NeuMoDx Molecular, Inc.
Technical details
Intended Use
NeuMoDx Lysis Buffer 2 is a proprietary buffer used to effectively extract nucleic acids from untreated clinical or biological specimens on the NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System ((c) NeuMoDx Systems) when used in conjunction with other NeuMoDx reagents such as the NeuMoDx Extraction Plate, NeuMoDx Wash Reagent and NeuMoDx Release Reagent, for all tests processed on NeuMoDx Systems. NeuMoDx Lysis Buffer 2 can be used to extract nucleic acids from clinical or biological specimens when used in combination with the designated NeuMoDx Test Strips.
Dates and status
Registration Date
Jun 06, 2024
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About this record

Access comprehensive regulatory information for IVD for enzymatic digestion, used for the extraction of nucleic acids 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 240001096/PCBA-HN and manufactured by NeuMoDx Molecular, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ KHOA HỌC VÀ CÔNG NGHỆ QMEDIC.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including NeuMoDx Molecular, Inc., and 1 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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