Taiwan FDA registration af820341e10f0a7b91c6fb347bf58f0a

Calibration solution and quality control solution of apex lipoprotein (a) test reagent group

TW: 亞培脂蛋白(a)檢驗試劑組之校正液及品管液
Taiwan flagTaiwan·Risk Class 2·BIOKIT S.A.·Registered Feb 07, 2020 – Feb 07, 2030Active
Registration details
Analysis ID
af820341e10f0a7b91c6fb347bf58f0a
Customs Code
DHA05603327104
Company information
Manufacturer
BIOKIT S.A.
Manufacturer Country
Spain
Product details
Intended Use
Calibration Solution: This product is used to establish the calibration curve of the "Abbot" lipoprotein (a) assay set (unsterilized) on the Ainity c analyzer by turbidimetry. Pipeline Solution: This product is used as an analyzed quality management material when using turbidity method in combination with the "Apep" lipoprotein (a) assay set (unsterilized) on the Ainity c analyzer.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration
Import Information
import
Dates and status
Registration Date
Feb 07, 2020
Expiry Date
Feb 07, 2030
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About this record

Access comprehensive regulatory information for Calibration solution and quality control solution of apex lipoprotein (a) test reagent group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number af820341e10f0a7b91c6fb347bf58f0a and manufactured by BIOKIT S.A.. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including BIOKIT S.A., and 1 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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