Quantitative Test Card for Na, K, iCa, pH, PCO2, PO2, TCO2, HCO3, BE, sO2, Hematocrit (Hct), Hemoglobin (Hgb)
Vietnam·Risk Class TTBYT Loại C·i-STAT EG7+ Cartridge·Abbott Point of Care Canada Limited·Registered Nov 14, 2024- Analysis ID
- 2403543ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-240705-0012
- Product Type
- i-STAT EG7+ Cartridge
- Product Code
- 03P76-25
- Manufacturer
- Abbott Point of Care Canada Limited
- Manufacturer Country
- CANADA
- Product Owner
- Abbott Point of Care Inc.
- Authorized Representative
- CÔNG TY TNHH TRANSMEDIC HEALTHCARE
- Intended Use
- The quantitative Na, K, iCa, pH, PCO2, PO2, TCO2, HCO3, BE, sO2, Hematocrit (Hct), Hemoglobin (Hgb) test cards, when used with the i-STAT 1 system, are intended for in vitro quantitative determination of sodium, potassium, ionized calcium, hematocrit, pH, partial pressure of oxygen and partial pressure of carbon dioxide in the whole blood, arterial, venous or capillary blood.
- Registration Date
- Nov 14, 2024
Access comprehensive regulatory information for Quantitative Test Card for Na, K, iCa, pH, PCO2, PO2, TCO2, HCO3, BE, sO2, Hematocrit (Hct), Hemoglobin (Hgb) in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403543ĐKLH/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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