Taiwan FDA registration 2e454ccffe931dfb560ba90e87d04b5d
"Instrument Lab" cassette for gem blood gas analyzers
TW: “儀器實驗室”寶石血液氣體分析儀專用卡匣
Taiwan·Risk Class 2·INSTRUMENTATION LABORATORY CO.·Registered Jun 26, 2012 – Jun 26, 2027ActiveRegistration details
- Analysis ID
- 2e454ccffe931dfb560ba90e87d04b5d
- Customs Code
- DHA00602366207
Company information
- Manufacturer
- INSTRUMENTATION LABORATORY CO.
- Manufacturer Country
- United States
- Authorized Representative
- Werfen Taiwan Limited
Product details
- Intended Use
- Detect the concentration and calculation parameters of pH, blood gas, blood volume ratio, electrolyte, glucose and lactic acid in whole blood. Must be used with the GEM Premier 3500 analyzer.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1120 血內氣體(PCO2,PO2)及血液pH值試驗系統
- Import Information
- import
Dates and status
- Registration Date
- Jun 26, 2012
- Expiry Date
- Jun 26, 2027
About this record
Access comprehensive regulatory information for "Instrument Lab" cassette for gem blood gas analyzers in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 2e454ccffe931dfb560ba90e87d04b5d and manufactured by INSTRUMENTATION LABORATORY CO.. The authorized representative in Taiwan is Werfen Taiwan Limited.
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