Taiwan FDA registration 79a0fb255790090225d85de08811ab56
Roche Cobas immunoassay troponin I rapid test reagent
TW: 羅氏可霸斯免疫分析肌鈣蛋白I快速檢驗試劑
Taiwan·Risk Class 2·ROCHE DIAGNOSTICS GMBH·Registered Feb 04, 2010 – Feb 04, 2015CancelledRegistration details
- Analysis ID
- 79a0fb255790090225d85de08811ab56
- Customs Code
- DHA00602081007
Company information
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- Roche Medical Instruments Co., Ltd
Product details
- Intended Use
- 使用免疫分析法體外定量測定人類血清和血漿中的心肌肌鈣蛋白I (cardiac troponin I). Troponin I STAT可以協助診斷心肌梗塞.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1215 Creatine phosphokinase/creatine kinase or isoenzyme testing system
Dates and status
- Registration Date
- Feb 04, 2010
- Expiry Date
- Feb 04, 2015
- 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 Cobas immunoassay troponin I rapid 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 79a0fb255790090225d85de08811ab56 and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is Roche Medical Instruments Co., Ltd.
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