Vietnam MOH registration 2400891ĐKLH/BYT-HTTB

IVD Department for quantitative pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, Glu, Lac

VN: Bộ IVD xét nghiệm định lượng pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, Glu, Lac

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·NOVA BIOMEDICAL CORPORATION·Registered Jun 24, 2024

Registration details

Analysis ID: 2400891ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220504-0081
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: NOVA BIOMEDICAL CORPORATION
Manufacturer Country: Theo theo phụ lục
Product Owner: NOVA BIOMEDICAL CORPORATION
Authorized Representative: CÔNG TY TNHH THƯƠNG MẠI Y TẾ PHÚ GIA

Technical details

Intended Use: 53455-Prime Auto QC Cartridge CCS 100 Sample, 45150-Prime Auto QC Cartridge CCS 200 Sample, 52864-Prime Auto QC Cartridge CCS 300 Sample: The automated quality control chemical cartridge used in in vitro diagnosis, designed for use by professionals to monitor the working state of StatProfile Prime CCS 52714-Prime Ampuled Control ABG/CCS: Used in in vitro diagnosis to monitor the working state of Nova Biomedical Prime 52427-Prime Calibrator Cartridge CCS Comp 100 Sample ,52861-Prime Calibrator Cartridge CCS Comp 200 Sample ,53105-Prime Calibrator Cartridge CCS Comp 300 Sample ,53365-Prime Calibrator Cartridge CCS Comp 400 Sample ,53469-Prime Calibrator Cartridge CCS Comp 500 Sample ,53470-Prime Calibrator Cartridge CCS Comp 600 Sample: The calibration chemical cartridge designed to calibrate pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, Glucose (Glu) and Lactate (Lac) using the Stat Profile Prime CCS Analyzer 42033-Prime Sensor Card CCS Comp; 52664-Prime Sensor Card CCS Comp (High Volume); 64251-Prime Sensor Card CCS Comp 100: To quantitatively detect pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, Glu (Glucose), and Lac (Lactate) in heparinized whole blood.

Dates and status

Registration Date: Jun 24, 2024

About this record

Access comprehensive regulatory information for IVD Department for quantitative pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, Glu, Lac 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 2400891ĐKLH/BYT-HTTB and manufactured by NOVA BIOMEDICAL CORPORATION. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI Y TẾ PHÚ GIA.

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