Taiwan FDA registration 0e57c3888e19c0c8605e5d896a5c3521

Abbott Drug Abuse Test Set-Tube Solution 1

TW: 亞培藥物濫用檢驗試劑組-品管液1
Taiwan flagTaiwan·Risk Class 2·MICROGENICS CORPORATION·Registered Sep 25, 2020 – Sep 25, 2025Expired
Registration details
Analysis ID
0e57c3888e19c0c8605e5d896a5c3521
Customs Code
DHA05603367808
Company information
Manufacturer Country
United States
Product details
Intended Use
This product is used on the Alinity c analyzer for the detection of amphetamine/methamphetamine, barbiturates, cocaine metabolites, methadone, opiates, phencyclidineand propoxyphene's drug of abuse (DOA) analysis for quality management. The Abbott Cocaine Test Group detects benzoylecgonine in human urine. This product is an unassayed quality control solution. This product (08P6318) is used on the Alinity c analyzer for the detection of amphetamine/methamphetamine, barbiturates, benzodiazepines, cocaine metabolites, methadone, methadone, Opiates, phencyclidine and propoxyphene drug abuse (DOA) analysis for quality management. The Abbott Cocaine Test Group detects benzoylecgonine in human urine. This product is an unassayed quality control solution.
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
Input;; QMS/QSD
Dates and status
Registration Date
Sep 25, 2020
Expiry Date
Sep 25, 2025
About this record

Access comprehensive regulatory information for Abbott Drug Abuse Test Set-Tube Solution 1 in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 0e57c3888e19c0c8605e5d896a5c3521 and manufactured by MICROGENICS CORPORATION. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

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