Taiwan FDA registration 0dfd7891d2cfab6e444557881b26869b

"Abbot" Eifinin albumin creatinine test group

TW: “亞培”艾菲寧白蛋白肌酸酐檢驗試劑組

Taiwan·Risk Class 2·ABBOTT DIAGNOSTICS TECHNOLOGIES AS·Registered Jun 03, 2016 – Jun 03, 2026Expired

Registration details

Analysis ID: 0dfd7891d2cfab6e444557881b26869b
Customs Code: DHA05602843807

Company information

Manufacturer: ABBOTT DIAGNOSTICS TECHNOLOGIES AS
Manufacturer Country: Norway
Authorized Representative: Abbott Rapid Diagnostics Health Corp.

Product details

Intended Use: This product is suitable for quantitative determination of human urine albumin, creatinine and albumin to creatinine ratio (ACR), and needs to be used with Alere Afinion AS100 Analyzer/Afinion2 Analyzer.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1645 尿蛋白質或白蛋白(非定量)試驗系統;; A.1660 品管材料(分析與非分析);; A.1225 肌氨酸酐試驗系統(Creatininetestsystem)
Import Information: import

Dates and status

Registration Date: Jun 03, 2016
Expiry Date: Jun 03, 2026

About this record

Access comprehensive regulatory information for "Abbot" Eifinin albumin creatinine test group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 0dfd7891d2cfab6e444557881b26869b and manufactured by ABBOTT DIAGNOSTICS TECHNOLOGIES AS. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..

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