Pre-assay calcitonin test reagent for Roche immunoassay
Taiwan·Risk Class 2·ROCHE DIAGNOSTICS GMBH·Registered Jun 01, 2023 – Jun 01, 2028Active- Analysis ID
- 4d7b63a05b0589f6cecc4af30f593e75
- Customs Code
- DHA05603618309
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- ROCHE DIAGNOSTICS LTD.
- Intended Use
- This product uses electrochemiluminescence immunoassay (ECLIA) with cobas e immunoassay to quantitatively detect procalcitonin (PCT) in human serum and plasma in vitro.
- Product Type (Level 1)
- A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
- Product Type (Level 2)
- C.3210 Endotoxin Analysis Test;; A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration
- Import Information
- QMS/QSD;; 輸入
- Registration Date
- Jun 01, 2023
- Expiry Date
- Jun 01, 2028
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Access comprehensive regulatory information for Pre-assay calcitonin test reagent for Roche immunoassay in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4d7b63a05b0589f6cecc4af30f593e75 and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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