Taiwan FDA registration fa82ca701a0f68c70bf1bfcceb5499ae

Immediate confirmation Platelet agglutination assay set (aspirin assay)

TW: 立即確認血小板凝集檢測試劑組(阿斯匹靈分析法)

Taiwan·Risk Class 2·ACCUMETRICS, INC.·Registered Apr 07, 2011 – Apr 07, 2016Cancelled

Registration details

Analysis ID: fa82ca701a0f68c70bf1bfcceb5499ae
Customs Code: DHA00602197801

Company information

Manufacturer: ACCUMETRICS, INC.
Manufacturer Country: United States
Authorized Representative: MEDDRAGON TECHNOLOGY CO., LTD.

Product details

Intended Use: This panel is a qualitative test performed by VerifyNow Instrument using whole blood containing citrate as an anticoagulant to measure platelet dysfunction caused by aspirin use in the laboratory or point-of-care unit.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.5700 Automated platelet agglutination system
Import Information: import

Dates and status

Registration Date: Apr 07, 2011
Expiry Date: Apr 07, 2016
Cancellation Date: May 17, 2018

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for Immediate confirmation Platelet agglutination assay set (aspirin assay) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number fa82ca701a0f68c70bf1bfcceb5499ae and manufactured by ACCUMETRICS, INC.. The authorized representative in Taiwan is MEDDRAGON TECHNOLOGY CO., LTD..

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