Taiwan FDA registration f0d354c148cbef21ae9a809048aa8f23
"Altona" BKV PCR Kit (Non-Sterile)
TW: "阿爾托納" BK病毒核酸試劑組 (未滅菌)
Taiwan·Risk Class 1·MD·ALTONA DIAGNOSTICS GMBH·Registered Oct 26, 2016 – Oct 26, 2021ExpiredRegistration details
- Analysis ID
- f0d354c148cbef21ae9a809048aa8f23
- License Form
- Ministry of Health Medical Device Import No. 017121
- Customs Code
- DHA09401712100
Company information
- Manufacturer
- ALTONA DIAGNOSTICS GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- HEALTHYOU CO., LTD.
Product details
- Intended Use
- BK virus DNA real-time PCR test to assess the likelihood of hemorrhagic cystitis in bone marrow transplant patients or kidney damage in kidney transplant patients.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C9999 Other
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Oct 26, 2016
- Expiry Date
- Oct 26, 2021
About this record
Access comprehensive regulatory information for "Altona" BKV PCR Kit (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 f0d354c148cbef21ae9a809048aa8f23 and manufactured by ALTONA DIAGNOSTICS GMBH. The authorized representative in Taiwan is HEALTHYOU CO., LTD..
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