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"Max" multi-drug analysis quality control group - Taiwan Registration f28a50a1ce186701b18f259e73a97748

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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f28a50a1ce186701b18f259e73a97748
Registration Details
Taiwan FDA Registration: f28a50a1ce186701b18f259e73a97748
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Device Details

"Max" multi-drug analysis quality control group
TW: โ€œ้บฅๆ–ฏโ€ ๅคš้‡่—ฅ็‰ฉๅˆ†ๆžๅ“็ฎก็ต„
Risk Class 2

Registration Details

f28a50a1ce186701b18f259e73a97748

DHA05603619200

Company Information

United States

Product Details

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.

A Clinical chemistry and clinical toxicology

A.1660 Quality control materials (analytical and non-analytical)

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Jun 17, 2023

Jun 17, 2028