Taiwan FDA registration f28a50a1ce186701b18f259e73a97748
"Max" multi-drug analysis quality control group
TW: “麥斯” 多重藥物分析品管組
Taiwan·Risk Class 2·MICROGENICS CORPORATION·Registered Jun 17, 2023 – Jun 17, 2028ActiveRegistration details
- Analysis ID
- f28a50a1ce186701b18f259e73a97748
- Customs Code
- DHA05603619200
Company information
- Manufacturer
- MICROGENICS CORPORATION
- Manufacturer Country
- United States
- Authorized Representative
- THERMO FISHER SCIENTIFIC TAIWAN CO., LTD.
Product details
- Intended Use
- This product is used as a stable test sample at known concentrations for the monitoring of semi-quantitative detection of benzodiazepines and barbiturates in human serum and plasma and tricyclic antidepressant drugs (TCA) in human serum, plasma and urine. Detection values are available for the specific systems listed. By comparing the measured values with the expected range, the user can ensure the performance stability of the detection reagent and the instrument.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical)
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Jun 17, 2023
- Expiry Date
- Jun 17, 2028
About this record
Access comprehensive regulatory information for "Max" multi-drug analysis quality control group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f28a50a1ce186701b18f259e73a97748 and manufactured by MICROGENICS CORPORATION. The authorized representative in Taiwan is THERMO FISHER SCIENTIFIC TAIWAN CO., LTD..
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