Taiwan FDA registration 00305bc1691f3b327b29bfa6bb8ad150
Abbott second generation amylase assay set
TW: 亞培第二代澱粉酶檢驗試劑組
Taiwan·Risk Class 2·ABBOTT IRELAND DIAGNOSTICS DIVISION·Registered Dec 09, 2021 – Dec 09, 2026ActiveRegistration details
- Analysis ID
- 00305bc1691f3b327b29bfa6bb8ad150
- Customs Code
- DHA05603491909
Company information
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Manufacturer Country
- Ireland
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- This product is used to quantify amylase in human serum, plasma or urine on the Alinity c System.
- 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
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Dec 09, 2021
- Expiry Date
- Dec 09, 2026
About this record
Access comprehensive regulatory information for Abbott second generation amylase 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 00305bc1691f3b327b29bfa6bb8ad150 and manufactured by ABBOTT IRELAND DIAGNOSTICS DIVISION. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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