Taiwan FDA registration 16aef9404827a85c9f7e7e9b25c50aeb
VITEK 2 Streptococcus AST
TW: 微鐵克2鏈球菌藥敏卡抗生素
Taiwan·Risk Class 2·MD·bioMérieux, Inc.·Registered Apr 05, 2018 – Apr 05, 2028ActiveRegistration details
- Analysis ID
- 16aef9404827a85c9f7e7e9b25c50aeb
- License Form
- Ministry of Health Medical Device Import No. 030535
- Customs Code
- DHA05603053500
Company information
- Manufacturer
- bioMérieux, Inc.
- Manufacturer Country
- United States
- Authorized Representative
- Hong Kong Commercial Mérieux S.p.A. Taiwan Branch
Product details
- Intended Use
- This product is equipped with Microtek 2 automatic microbial analyzer to measure the antibiotic susceptibility of Streptococcus pneumoniae, β hemolytic streptococcus and Streptococcus virida in clinical laboratories.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C1645 Automatic Short Incubation Period Antibiotic Susceptibility Testing System
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Apr 05, 2018
- Expiry Date
- Apr 05, 2028
About this record
Access comprehensive regulatory information for VITEK 2 Streptococcus AST in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 16aef9404827a85c9f7e7e9b25c50aeb and manufactured by bioMérieux, Inc.. The authorized representative in Taiwan is Hong Kong Commercial Mérieux S.p.A. Taiwan Branch.
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