Taiwan FDA registration 5fd26fb49f84d46f02e859ea8aea8367

Mycobacterium tuberculosis MPT64 antigen rapid test reagent (unsterilized)

TW: “速帝”結核桿菌MPT64抗原快速檢驗試劑 (未滅菌)

Taiwan·Risk Class 1·STANDARD DIAGNOSTICS, INC.·Registered Aug 12, 2010 – Aug 12, 2015Cancelled

Registration details

Analysis ID: 5fd26fb49f84d46f02e859ea8aea8367
Customs Code: DHA04400909000

Company information

Manufacturer: STANDARD DIAGNOSTICS, INC.
Manufacturer Country: Korea, Republic of
Authorized Representative: Ariel Health Inc

Product details

Intended Use: Limited to the first level identification range of Mycobacterium tuberculosis immunofluorescent reagent (C.3370) of the management method for medical devices.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3370 結核桿菌免疫螢光試劑
Import Information: import

Dates and status

Registration Date: Aug 12, 2010
Expiry Date: Aug 12, 2015
Cancellation Date: Apr 25, 2018

Cancellation information

Status: Logged out
Reason: 自行鍵入

About this record

Access comprehensive regulatory information for Mycobacterium tuberculosis MPT64 antigen rapid test reagent (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 5fd26fb49f84d46f02e859ea8aea8367 and manufactured by STANDARD DIAGNOSTICS, INC.. The authorized representative in Taiwan is Ariel Health Inc.

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