Taiwan FDA registration 6639cd69a5863693ce9b6a88f71f05a2

"Abbot" Mycobacterium tuberculosis MPT64 antigen rapid diagnostic reagent (unsterilized)

TW: "亞培" 百而靈結核桿菌MPT64抗原快速診斷試劑(未滅菌)

Taiwan·Risk Class 1·ABBOTT DIAGNOSTICS KOREA INC·Registered Jun 15, 2010 – Jun 15, 2025Expired

Registration details

Analysis ID: 6639cd69a5863693ce9b6a88f71f05a2
Customs Code: DHA04400891402

Company information

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

Product details

Intended Use: Limited to the classification and grading management method of medical equipment, Mycobacterium tuberculosis immunofluorescent reagent (C.3370) first level identification range.
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: Jun 15, 2010
Expiry Date: Jun 15, 2025

About this record

Access comprehensive regulatory information for "Abbot" Mycobacterium tuberculosis MPT64 antigen rapid diagnostic 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 6639cd69a5863693ce9b6a88f71f05a2 and manufactured by ABBOTT DIAGNOSTICS KOREA INC. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..

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