Taiwan FDA registration 4f81dfc589916d7fdcf819750953ea89

Immediate confirmation of adenosine diphosphate P2Y12 receiver detection set

TW: 立即確認腺核苷二磷酸P2Y12接受器檢測試劑組

Taiwan·Risk Class 2·ACCUMETRICS, INC.·Registered Apr 14, 2011 – Apr 14, 2016Cancelled

Registration details

Analysis ID: 4f81dfc589916d7fdcf819750953ea89
Customs Code: DHA00602198508

Company information

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

Product details

Intended Use: Paired with an immediate confirmation analyzer to measure the blockade of the platelet P2Y12 receiver. Confirm Now The Adenucleoside Diphosphate P2Y12 Receptor Assay is a whole blood test that can be used in the laboratory or point-of-care unit to measure platelet P2Y12 receptor blockade. Intended Use: To identify patients with high residual platelet activity (HRPR) or who respond poorly to a high risk of future cardiovascular events.
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 14, 2011
Expiry Date: Apr 14, 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 of adenosine diphosphate P2Y12 receiver detection set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4f81dfc589916d7fdcf819750953ea89 and manufactured by ACCUMETRICS, INC.. The authorized representative in Taiwan is MEDDRAGON TECHNOLOGY CO., LTD..

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