Taiwan FDA registration c65b075a8ca506c3142265d0bb414a0a

Meieliel Inrixiu prothrombin time/international standard ratio test card

TW: 美艾利爾　因芮修　凝血酶原時間/國際標準比值檢測卡片

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

Registration details

Analysis ID: c65b075a8ca506c3142265d0bb414a0a
Customs Code: DHA00602192401

Company information

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

Product details

Intended Use: The INRatio/INRatio2 PT monitoring system quantitatively measures coagulation time (PT) using fresh capillary whole blood. The INRatio/ 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 INRatio/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: Dec 09, 2010
Expiry Date: Dec 09, 2020
Cancellation Date: Aug 30, 2017

Cancellation information

Status: Logged out
Reason: 自請註銷

About this record

Access comprehensive regulatory information for Meieliel Inrixiu prothrombin time/international standard ratio test card in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c65b075a8ca506c3142265d0bb414a0a and manufactured by ALERE SAN DIEGO, INC.. The authorized representative in Taiwan is Ariel Health Inc.

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