Taiwan FDA registration d3f6ab74eccecce581bd2e7581229eff
Apecethase assay set
TW: 亞培澱粉酶檢驗試劑組
Taiwan·Risk Class 2·ABBOTT GMBH;; SEKISUI DIAGNOSTICS P.E.I. INC.·Registered Apr 02, 2019 – Apr 02, 2029ActiveRegistration details
- Analysis ID
- d3f6ab74eccecce581bd2e7581229eff
- Customs Code
- DHA05603239504
Company information
- Manufacturer
- ABBOTT GMBH;; SEKISUI DIAGNOSTICS P.E.I. INC.
- Manufacturer Country
- Canada;;Germany
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- This product is used with an Alinity c analyzer for the quantitative analysis of amylase in human serum or plasma.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1070 澱粉酶試驗系統
- Import Information
- 委託製造;; QMS/QSD;; 輸入
Dates and status
- Registration Date
- Apr 02, 2019
- Expiry Date
- Apr 02, 2029
About this record
Access comprehensive regulatory information for Apecethase assay set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number d3f6ab74eccecce581bd2e7581229eff and manufactured by ABBOTT GMBH;; SEKISUI DIAGNOSTICS P.E.I. INC.. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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