Taiwan FDA registration 220980c0c75633815c928d712f010dea

"Sodi" Mycobacterium tuberculosis antibody rapid test reagent (unsterilized)

TW: “速帝”結核桿菌抗體快速檢驗試劑(未滅菌)

Taiwan·Risk Class 1·STANDARD DIAGNOSTICS, INC.·Registered Aug 12, 2010 – Aug 12, 2020Cancelled

Registration details

Analysis ID: 220980c0c75633815c928d712f010dea
Customs Code: DHA04400908000

Company information

Manufacturer: STANDARD DIAGNOSTICS, INC.
Manufacturer Country: Korea, Republic of
Authorized Representative: Abbott Rapid Diagnostics Health Corp.

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, 2020
Cancellation Date: Jul 15, 2022

Cancellation information

Status: Logged out
Reason: 未展延而逾期者

About this record

Access comprehensive regulatory information for "Sodi" Mycobacterium tuberculosis antibody 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 220980c0c75633815c928d712f010dea and manufactured by STANDARD DIAGNOSTICS, INC.. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..

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