Taiwan FDA registration 55883371694e6757b9b221aa14fcb618
"Kipfu" BK Virus Nucleic Acid Test Reagent Set (Non-sterilized)
TW: "基普復" BK 病毒核酸檢驗試劑組(未滅菌)
Taiwan·Risk Class 1·GeneProof a. s.·Registered Feb 27, 2024 – Feb 27, 2029ActiveRegistration details
- Analysis ID
- 55883371694e6757b9b221aa14fcb618
- Customs Code
- DHA09402340704
Company information
- Manufacturer
- GeneProof a. s.
- Manufacturer Country
- Czechia
- Authorized Representative
- MEDTRI CO., LTD.
Product details
- Intended Use
- This product utilizes real-time polymerase chain reaction (PCR) for the qualitative and quantitative detection of BK virus DNA in human cerebrospinal fluid, plasma, whole blood, or urine samples. The results of this product test must be evaluated in conjunction with clinical symptoms and other relevant laboratory findings.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.9999 Miscellaneous
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Feb 27, 2024
- Expiry Date
- Feb 27, 2029
About this record
Access comprehensive regulatory information for "Kipfu" BK Virus Nucleic Acid Test Reagent Set (Non-sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 55883371694e6757b9b221aa14fcb618 and manufactured by GeneProof a. s.. The authorized representative in Taiwan is MEDTRI CO., LTD..
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