Taiwan FDA registration 54832194ebf8782eaf4ed30407f81c28

Hydrostatic norudia urine albumin determination correction solution and quality control solution

TW: 積水諾魯帝亞尿液白蛋白測定校正液及品管液
Taiwan flagTaiwan·Risk Class 2·SEKISUI MEDICAL CO., LTD. TSUKUBA PLANT·Registered Aug 11, 2017 – Aug 11, 2027Active
Registration details
Analysis ID
54832194ebf8782eaf4ed30407f81c28
Customs Code
DHA05602982506
Company information
Manufacturer Country
Japan
Authorized Representative
KUO'S YUAN IN ENTERPRISE CO., LTD.
Product details
Intended Use
This product is used by NORUDIA U-ALB, with an automatic analysis device to detect urine albumin, and is used as a correction solution (calibrator) and quality control solution (control).
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
Aug 11, 2017
Expiry Date
Aug 11, 2027
About this record

Access comprehensive regulatory information for Hydrostatic norudia urine albumin determination correction solution and quality control solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 54832194ebf8782eaf4ed30407f81c28 and manufactured by SEKISUI MEDICAL CO., LTD. TSUKUBA PLANT. The authorized representative in Taiwan is KUO'S YUAN IN ENTERPRISE CO., LTD..

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