Taiwan FDA registration a2404be6881e3feb01b7a07971dd9e2d
Automatic enzyme linked immunoassay system for diagnosis of Innovadas autoimmune diseases (unsterilized)
TW: 因諾瓦達斯自體免疫疾病診斷用之自動酵素連結免疫分析系統 (未滅菌)
Registration details
- Analysis ID
- a2404be6881e3feb01b7a07971dd9e2d
- Customs Code
- DHA04400532902
Company information
- Manufacturer
- INOVA DIANOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- Limited to the first level identification range of enzyme analyzer for clinical use (A.2500) of the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.2500 Enzyme analyzer for clinical use
- Import Information
- import
Dates and status
- Registration Date
- Nov 13, 2006
- Expiry Date
- Nov 13, 2016
- Cancellation Date
- Aug 09, 2018
Cancellation information
- Status
- Logged out
- Reason
- 未展延而逾期者
About this record
Access comprehensive regulatory information for Automatic enzyme linked immunoassay system for diagnosis of Innovadas autoimmune diseases (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number a2404be6881e3feb01b7a07971dd9e2d and manufactured by INOVA DIANOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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