“Roche” cobas BKV (Non-Sterile)
Taiwan·Risk Class 1·MD·Roche Molecular Systems, Inc.·Registered Oct 13, 2020 – Oct 13, 2025Expired- Analysis ID
- 8a55972153768444a43b670e56625dea
- License Form
- Ministry of Health Medical Device Import No. 022021
- Customs Code
- DHA09402202103
- 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 and cobas PCR media-fixed urine samples. This product is intended to assist in the diagnosis and monitoring of BK virus load in transplant patients. When used in EDTA plasma, viral DNA can be measured serially in patients under BK virus surveillance to assess the need for treatment changes 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. This product is not intended for screening of blood or blood products.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C9999 Other
- Import Information
- Imported from abroad
- Registration Date
- Oct 13, 2020
- Expiry Date
- Oct 13, 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 8a55972153768444a43b670e56625dea and manufactured by Roche Molecular Systems, Inc.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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