Taiwan FDA registration 4564c900355d969ced69c0a19d086348
VIDAS Anti-TPO
TW: 威達獅甲狀腺過氧化酶抗體試劑組
Registration details
- Analysis ID
- 4564c900355d969ced69c0a19d086348
- License Form
- Ministry of Health Medical Device Import No. 027354
- Customs Code
- DHA05602735409
Company information
- Manufacturer
- BIOMERIEUX S.A.
- Manufacturer Country
- France
- Authorized Representative
- Hong Kong Commercial Mérieux S.p.A. Taiwan Branch
Product details
- Intended Use
- This product is an automated quantitative assay for the VIDAS series of instruments to test thyroid peroxidase IgG autoantibodies in human serum or plasma using ELFA technology (enzyme-linked fluorescence analysis).
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C5870 Thyroid autoantibody immunoassay system
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jun 22, 2015
- Expiry Date
- Jun 22, 2025
About this record
Access comprehensive regulatory information for VIDAS Anti-TPO in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4564c900355d969ced69c0a19d086348 and manufactured by BIOMERIEUX S.A.. The authorized representative in Taiwan is Hong Kong Commercial Mérieux S.p.A. Taiwan Branch.
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