Taiwan FDA registration 1e5b19d09cbbeb2b755484593aff37dd
“Abbott” ASO Reagent Kit (Non-Sterile)
TW: “亞培” 抗鏈球菌溶血素O檢驗試劑組(未滅菌)
Taiwan·Risk Class 1·MD·BIOKIT S.A.·Registered Aug 22, 2018 – Aug 22, 2028ActiveRegistration details
- Analysis ID
- 1e5b19d09cbbeb2b755484593aff37dd
- License Form
- Ministry of Health Medical Device Import No. 019530
- Customs Code
- DHA09401953001
Company information
- Manufacturer
- BIOKIT S.A.
- Manufacturer Country
- Spain
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- Limited to the management of medical devices: Streptococcus is an extracellular enzyme reagent (C.3720) in the first grade identification range.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3720 Streptococcus is an extracellular enzyme reagent
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Aug 22, 2018
- Expiry Date
- Aug 22, 2028
About this record
Access comprehensive regulatory information for “Abbott” ASO Reagent Kit (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 1e5b19d09cbbeb2b755484593aff37dd and manufactured by BIOKIT S.A.. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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