Taiwan FDA registration 44774d6b23d5b4db481ad7665e9ae6e4
Sismer linear range quality tube blood
TW: 西斯美線性範圍品管血液
Taiwan·Risk Class 2·LINE·Registered Apr 11, 2011 – Apr 11, 2016CancelledRegistration details
- Analysis ID
- 44774d6b23d5b4db481ad7665e9ae6e4
- Customs Code
- DHA00602198100
Company information
- Manufacturer
- LINE
- Manufacturer Country
- United States
- Authorized Representative
- Sandong Instrument Co., Ltd
Product details
- Intended Use
- This product has a total of 6 concentration points and is intended for use by laboratory professionals or appropriately trained personnel when validating the reportable range of the Sisme XE, XT, XS, K-Series and POCH-100i hematology analyzers in vitro.
- Product Type (Level 1)
- B Hematology, pathology, and genetics
- Product Type (Level 2)
- B.8625 Hematology Quality Control Mixtures
- Import Information
- import
Dates and status
- Registration Date
- Apr 11, 2011
- Expiry Date
- Apr 11, 2016
- Cancellation Date
- Jul 31, 2018
Cancellation information
- Status
- Logged out
- Reason
- 未展延而逾期者
About this record
Access comprehensive regulatory information for Sismer linear range quality tube blood in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 44774d6b23d5b4db481ad7665e9ae6e4 and manufactured by LINE. The authorized representative in Taiwan is Sandong Instrument Co., Ltd.
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