Taiwan FDA registration 7e426b9f83c35d75a677e8b35074d5cc

Elite Innyl Repair 2nd generation prothrombin time/international standard ratio professional monitoring system

TW: 美艾利爾因芮修第二代凝血酶原時間/國際標準比值專業型監控系統

Taiwan·Risk Class 2·ALERE SAN DIEGO, INC.·Registered Nov 09, 2010 – Nov 09, 2020Cancelled

Registration details

Analysis ID: 7e426b9f83c35d75a677e8b35074d5cc
Customs Code: DHA00602168305

Company information

Manufacturer: ALERE SAN DIEGO, INC.
Manufacturer Country: United States
Authorized Representative: Ariel Health Inc

Product details

Intended Use: The INRatio2 PT monitoring system quantifies coagulation time (PT) in fresh capillary whole blood. The INRatio2 PT monitoring system is for in vitro diagnostic use only and is intended for patients on warfarin and other oral anticoagulant (hemodilution) therapies to monitor the clotting time of their blood. The INRatio2 PT monitoring system should not be used for screening purposes.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.7750 Prothrombin time test
Import Information: import

Dates and status

Registration Date: Nov 09, 2010
Expiry Date: Nov 09, 2020
Cancellation Date: Sep 01, 2017

Cancellation information

Status: Logged out
Reason: 自請註銷

About this record

Access comprehensive regulatory information for Elite Innyl Repair 2nd generation prothrombin time/international standard ratio professional monitoring system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7e426b9f83c35d75a677e8b35074d5cc and manufactured by ALERE SAN DIEGO, INC.. The authorized representative in Taiwan is Ariel Health Inc.

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