“Roche” cobas BKV (Non-Sterile)
Taiwan·Risk Class 1·MD·Roche Molecular Systems, Inc.·Registered Jan 15, 2020 – Jan 15, 2025Expired- Analysis ID
- d646bcd2035054aad3d7e2789c9483e6
- License Form
- Ministry of Health Medical Device Import No. 021190
- Customs Code
- DHA09402119008
- Manufacturer
- Roche Molecular Systems, Inc.
- Manufacturer Country
- United States
- Authorized Representative
- ROCHE DIAGNOSTICS LTD.
- Intended Use
- This product is an in vitro nucleic acid amplification test for the quantification of BK virus (BKV) DNA in human EDTA plasma. This product is intended to assist in the diagnosis and monitoring of BK virus load in transplant patients. In patients who are monitored for BK virus, viral DNA can be measured serially to assess whether treatment needs to be changed and to assess the response of the virus to treatment. The results of this test must be evaluated in conjunction with other relevant clinical and laboratory findings.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C9999 Other
- Import Information
- Imported from abroad
- Registration Date
- Jan 15, 2020
- Expiry Date
- Jan 15, 2025
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Access comprehensive regulatory information for “Roche” cobas BKV (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 d646bcd2035054aad3d7e2789c9483e6 and manufactured by Roche Molecular Systems, Inc.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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