Vietnam MOH registration 230001842/PCBA-HN
In-house control of IVD during the process of nucleic acid extraction and amplification
VN: IVD kiểm soát nội bộ trong quá trình tách chiết và khuếch đại acid nucleic
Vietnam·Risk Class TTBYT Loại A·CPE – Internal Control·ELITechGroup S.p.A.·Registered Sep 25, 2023Registration details
- Analysis ID
- 230001842/PCBA-HN
- Submission ID
- 000.00.19.H26-230921-0001
- Product Type
- CPE – Internal Control
- Product Code
- CTRCPE
Company information
- Manufacturer
- ELITechGroup S.p.A.
- Manufacturer Country
- ITALY
Technical details
- Intended Use
- Internal Control CPE - Internal Control is a medical device for in vitro diagnosis, used by medical professionals as a control template for DNA and RNA extraction and amplification (the presence of nucleic acids and no inhibitors in the extracted product) with nucleic acid amplification tests, extraction chemicals, and equipment by ELITechGroup S.p.A.
Dates and status
- Registration Date
- Sep 25, 2023
About this record
Access comprehensive regulatory information for In-house control of IVD during the process of nucleic acid extraction and amplification 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 230001842/PCBA-HN and manufactured by ELITechGroup S.p.A..
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