Vietnam MOH registration 240002611/PCBB-HN

Procalcitonin (PCT) Quantitative Testing Drug

VN: Thuốc thử xét nghiệm định lượng Procalcitonin (PCT)

Vietnam·Risk Class TBYT Loại B·AFIAS PCT·Boditech Med Inc.·Registered Oct 03, 2024

Registration details

Analysis ID: 240002611/PCBB-HN
Submission ID: 000.00.19.H26-241002-0013
Product Type: AFIAS PCT
Product Code: SMFP-7

Company information

Manufacturer: Boditech Med Inc.
Product Owner: Boditech Med Inc.
Authorized Representative: CÔNG TY TNHH VẠN NIÊN

Technical details

Intended Use: AFIAS PCT is a fluorescent immunoassay (FIA) for the quantitative determination of PCT (procalcitonin) in whole blood/plasma/serum. It is very useful in supporting the diagnosis, management, and monitoring of infections and sepsis. It is intended for in vitro diagnostic use only.

Dates and status

Registration Date: Oct 03, 2024

About this record

Access comprehensive regulatory information for Procalcitonin (PCT) Quantitative Testing Drug in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002611/PCBB-HN and manufactured by Boditech Med Inc.. The authorized representative in Vietnam is CÔNG TY TNHH VẠN NIÊN.

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