Taiwan FDA registration 2f31008df5277f7c3efd2afe2aafd548

Ace Glycosylated Hemoglobin Analysis Reagent Group

TW: 尊爵醣化血色素分析試劑組

Taiwan·Risk Class 2·Trinity Biotech (Primus Corporation dba Trinity Biotech)·Registered Aug 06, 2012 – Aug 06, 2017Cancelled

Registration details

Analysis ID: 2f31008df5277f7c3efd2afe2aafd548
Customs Code: DHA00602383502

Company information

Manufacturer: Trinity Biotech (Primus Corporation dba Trinity Biotech)
Manufacturer Country: United States
Authorized Representative: PROGRESSIVE GROUP INC.

Product details

Intended Use: This product is used in conjunction with the Premier HB9210 System for the quantitative evaluation of glycosylated hemoglobin in human microvascular and venous whole blood samples. HbA1C can be used for long-term monitoring of blood glucose in diabetic patients, and is only used for in vitro diagnosis.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.7470 Analysis of glycosylated hemoglobin
Import Information: import

Dates and status

Registration Date: Aug 06, 2012
Expiry Date: Aug 06, 2017
Cancellation Date: Nov 21, 2019

Cancellation information

Status: Logged out
Reason: 未展延而逾期者

About this record

Access comprehensive regulatory information for Ace Glycosylated Hemoglobin Analysis 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 2f31008df5277f7c3efd2afe2aafd548 and manufactured by Trinity Biotech (Primus Corporation dba Trinity Biotech). The authorized representative in Taiwan is PROGRESSIVE GROUP INC..

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