Taiwan FDA registration 4500df59e1059a72c844047555cbe153
Roche drug monitoring pukainamide test reagent
TW: 羅氏藥物監測普卡因胺檢驗試劑
Registration details
- Analysis ID
- 4500df59e1059a72c844047555cbe153
- Customs Code
- DHA00602002402
Company information
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- Roche Medical Instruments Co., Ltd
Product details
- Intended Use
- The Roche/Hitachi cobas c system was used to quantify the concentration of putcainamide in serum and plasma in vitro trials.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.3320 毛地黃毒素試驗系統
- Import Information
- import
Dates and status
- Registration Date
- Jun 03, 2009
- Expiry Date
- Jun 03, 2014
- Cancellation Date
- May 28, 2018
Cancellation information
- Status
- Logged out
- Reason
- 許可證已逾有效期
About this record
Access comprehensive regulatory information for Roche drug monitoring pukainamide 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 4500df59e1059a72c844047555cbe153 and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is Roche Medical Instruments Co., Ltd.
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