Taiwan FDA registration b7e45db8c5f452bf7a7a23e28e3d1a87
"Kaijie" Ipsolgen human JAK2 gene detection reagent group
TW: “凱杰” 依譜索勁人類JAK2基因檢測試劑組
Taiwan·Risk Class 2·QIAGEN GMBH·Registered Jan 06, 2021 – Jan 06, 2026ExpiredRegistration details
- Analysis ID
- b7e45db8c5f452bf7a7a23e28e3d1a87
- Customs Code
- DHA05603418401
Company information
- Manufacturer
- QIAGEN GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- QIAGEN TAIWAN COMPANY LIMITED
Product details
- Intended Use
- This product is an in vitro quantitative test designed to detect the JAK2 V617F/G1849T allele in genomic DNA extracted from whole blood. This test is designed to assist in the diagnosis of myeloproliferative neoplasm (MPN) related to other clinicopathological factors.
- Product Type (Level 1)
- B Hematology, pathology, and genetics
- Product Type (Level 2)
- B.4020 Analysis of specific tests
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Jan 06, 2021
- Expiry Date
- Jan 06, 2026
About this record
Access comprehensive regulatory information for "Kaijie" Ipsolgen human JAK2 gene detection reagent group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b7e45db8c5f452bf7a7a23e28e3d1a87 and manufactured by QIAGEN GMBH. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.
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