Calibration standard and control material for quantitative pH, pCO2, pO2, cNa+, cK+, cCa2+, cCl-, cGlu, cLac, ctHb, sO2, FO2Hb, FCOHb, FMetHb, FHHb, FHbF, ctBil
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Radiometer Medical ApS·Registered Jun 24, 2024- Analysis ID
- 2400857ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-211130-0004
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Radiometer Medical ApS
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Radiometer Medical ApS
- Authorized Representative
- CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG
- Intended Use
- Solution Pack - SP90 is used to calibrate the sensor card, control quality, evaluate accuracy and precision, wash the measurement device, and collect waste from the electrolyte analysis machine, ABL90 FLEX and ABL90 FLEX PLUS. ABL90 FLEX and ABL90 FLEX PLUS are portable, automated blood gas analyzers that measure in vitro pH, pCO2, pO2, ctHb, sO2, FO2Hb, FCOHb, FMetHb, FHbF, FHHb, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, ctBil in whole blood samples. The intended purpose is to assist clinical decision-making in the diagnosis of disorders or conditions involving metabolism, respiration, endocrine, hematology, cardiovascular, and infectious processes. Solution Pack - SP90 is intended for use by trained technicians, nurses, physicians, and clinicians. The product is intended for use in the laboratory, at the point of care. There are no restrictions on the patient population intended to be treated, including age, weight, and gender.
- Registration Date
- Jun 24, 2024
Access comprehensive regulatory information for Calibration standard and control material for quantitative pH, pCO2, pO2, cNa+, cK+, cCa2+, cCl-, cGlu, cLac, ctHb, sO2, FO2Hb, FCOHb, FMetHb, FHHb, FHbF, ctBil 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 2400857ĐKLH/BYT-HTTB and manufactured by Radiometer Medical ApS. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG.
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