Taiwan FDA registration 6c080a189f72e5f989ff9de9b8f4b2ad
"Abbot" precision detection of treponemal antibody test reagent
TW: "亞培"精測梅毒螺旋體抗體檢驗試劑
Registration details
- Analysis ID
- 6c080a189f72e5f989ff9de9b8f4b2ad
- Customs Code
- DHA00601225203
Company information
- Manufacturer
- ABBOTT DIAGNOSTICS MEDICAL CO., LTD.-CHIBA PLANT
- Manufacturer Country
- Japan
- Authorized Representative
- Abbott Rapid Diagnostics Health Corp.
Product details
- Intended Use
- Immunochromatographic. It is an in vitro qualitative immunoassay reagent that can be interpreted by the naked eye to test human serum, plasma or whole blood against Treponema pallidum, the bacterium that causes syphilis infection.
- Product Type (Level 1)
- C Immunology and microbiology
- Import Information
- import
Dates and status
- Registration Date
- Sep 08, 2005
- Expiry Date
- Sep 08, 2025
About this record
Access comprehensive regulatory information for "Abbot" precision detection of treponemal antibody test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 6c080a189f72e5f989ff9de9b8f4b2ad and manufactured by ABBOTT DIAGNOSTICS MEDICAL CO., LTD.-CHIBA PLANT. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..
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