Taiwan FDA registration 11acb1a69b835dc4df376c49c675cd97

Holother B viral weight nucleic acid detection reagent

TW: 豪洛捷B型肝炎病毒量核酸檢測試劑
Taiwan flagTaiwan·Risk Class 3·HOLOGIC, INC.·Registered Jun 25, 2021 – Jun 25, 2026Expired
Registration details
Analysis ID
11acb1a69b835dc4df376c49c675cd97
Customs Code
DHA05603467000
Company information
Manufacturer
HOLOGIC, INC.
Manufacturer Country
United States
Authorized Representative
QUALTECH CONSULTING CORPORATION
Product details
Intended Use
Details are as detailed as approved Chinese instructions.
Product Type (Level 1)
B Hematology, pathology, and genetics
Product Type (Level 2)
B.4020 Analysis of specific tests
Import Information
Input;; QMS/QSD
Dates and status
Registration Date
Jun 25, 2021
Expiry Date
Jun 25, 2026
About this record

Access comprehensive regulatory information for Holother B viral weight nucleic acid detection reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 11acb1a69b835dc4df376c49c675cd97 and manufactured by HOLOGIC, INC.. The authorized representative in Taiwan is QUALTECH CONSULTING CORPORATION.

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