Taiwan FDA registration cdd17c57f22d2e65f23d37db3cd76344

Kebia partial thrombogenic time reagent

TW: 克比亞部分血栓形成質時間試劑

Taiwan·Risk Class 2·SEKISUI MEDICAL CO., LTD. TSUKUBA PLANT·Registered May 20, 2013 – May 20, 2018Cancelled

Registration details

Analysis ID: cdd17c57f22d2e65f23d37db3cd76344
Customs Code: DHA00602469208

Company information

Manufacturer: SEKISUI MEDICAL CO., LTD. TSUKUBA PLANT
Manufacturer Country: Japan
Authorized Representative: KUO'S YUAN IN ENTERPRISE CO., LTD.

Product details

Intended Use: 檢測血漿活化部分凝血活?時間(Activated Partial Thromboplastin Time; APTT)可廣泛做為篩檢凝血內部路徑、抗凝血劑肝素(heparin)治療監控、或檢測凝血因子抑制子(Factor inhibitor)等的檢查用途.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.7925 Partial thrombin time test
Import Information: import

Dates and status

Registration Date: May 20, 2013
Expiry Date: May 20, 2018
Cancellation Date: Nov 04, 2019

Cancellation information

Status: Logged out
Reason: 未展延而逾期者

About this record

Access comprehensive regulatory information for Kebia partial thrombogenic time reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number cdd17c57f22d2e65f23d37db3cd76344 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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