Taiwan FDA registration 4249e6f924cade343efa7f349aff39ea
Abestai Trusted Heme A1c Test Set
TW: 亞培愛可信血紅素 A1c 檢驗試劑組
Taiwan·Risk Class 2·AXIS-SHIELD DIAGNOSTICS LTD.·Registered Jun 10, 2009 – Jun 10, 2014CancelledRegistration details
- Analysis ID
- 4249e6f924cade343efa7f349aff39ea
- Customs Code
- DHA00602002501
Company information
- Manufacturer
- AXIS-SHIELD DIAGNOSTICS LTD.
- Manufacturer Country
- United Kingdom
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- Immunoassay is used to quantitatively measure heme A1c in human whole blood.
- Product Type (Level 1)
- B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration;; B.7470 Analysis of glycosylated hemoglobin
- Import Information
- import
Dates and status
- Registration Date
- Jun 10, 2009
- Expiry Date
- Jun 10, 2014
- Cancellation Date
- Aug 09, 2018
Cancellation information
- Status
- Logged out
- Reason
- 未展延而逾期者
About this record
Access comprehensive regulatory information for Abestai Trusted Heme A1c Test Set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4249e6f924cade343efa7f349aff39ea and manufactured by AXIS-SHIELD DIAGNOSTICS LTD.. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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