Taiwan FDA registration ca6ee9c809154013e0ddb2c329b26f38
"INOVA" Anti-β2-Glycoprotein 1 ELISA (Non-Sterile)
TW: "因諾瓦"免疫酵素法抗β2醣蛋白抗體試劑 (未滅菌)
Taiwan·Risk Class 1·MD·INOVA DIAGNOSTICS·Registered Dec 11, 2018 – Dec 11, 2023ExpiredRegistration details
- Analysis ID
- ca6ee9c809154013e0ddb2c329b26f38
- License Form
- Ministry of Health Medical Device Import No. 019906
- Customs Code
- DHA09401990607
Company information
- Manufacturer
- INOVA DIAGNOSTICS
- Manufacturer Country
- Spain
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- Limited to the first level recognition range of the medical device management method β-2-glycoprotein I immunoassay system (C.5430).
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C5430 β-2-glycoprotein I immunoassay system
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Dec 11, 2018
- Expiry Date
- Dec 11, 2023
About this record
Access comprehensive regulatory information for "INOVA" Anti-β2-Glycoprotein 1 ELISA (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 ca6ee9c809154013e0ddb2c329b26f38 and manufactured by INOVA DIAGNOSTICS. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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