Vietnam MOH registration 2403117ĐKLH/BYT-HTTB
pH Quantitative Test Card, PCO2, PO2, TCO2, HCO3, BE, sO2
VN: Thẻ xét nghiệm định lượng pH, PCO2, PO2, TCO2, HCO3, BE, sO2
Vietnam·Risk Class TBYT Loại C·i-STAT G3+ Cartridge·Abbott Point of Care Canada Limited·Registered Nov 02, 2024Registration details
- Analysis ID
- 2403117ĐKLH/BYT-HTTB
- Submission ID
- 19008582/ĐKLH-BYT-TB-CT
- Product Type
- i-STAT G3+ Cartridge
- Product Code
- 03P78-25
Company information
- Manufacturer
- Abbott Point of Care Canada Limited
- Manufacturer Country
- CANADA
- Product Owner
- Abbott Point of Care INC.
- Authorized Representative
- CÔNG TY TNHH TRANSMEDIC HEALTHCARE
Technical details
- Intended Use
- pH Quantitative Test Card, PCO2, PO2, TCO2, HCO3, BE, sO2 combined with the i-STAT Electrolyte Blood Gas Analyzer to be used for in vitro quantitative determination of pH, partial pressure of oxygen and partial pressure of carbon dioxide in the whole blood, arterial, venous or capillary blood.
Dates and status
- Registration Date
- Nov 02, 2024
About this record
Access comprehensive regulatory information for pH Quantitative Test Card, PCO2, PO2, TCO2, HCO3, BE, sO2 in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại C medical device is registered under number 2403117ĐKLH/BYT-HTTB and manufactured by Abbott Point of Care Canada Limited. The authorized representative in Vietnam is CÔNG TY TNHH TRANSMEDIC HEALTHCARE.
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