Taiwan FDA registration c11231057bf31635afa5a7f487650347
Espert hepatitis B virus detection kit
TW: 艾斯柏特B型肝炎病毒檢測試劑組
Taiwan·Risk Class 3·CEPHEID AB·Registered Feb 20, 2020 – Feb 20, 2030ActiveRegistration details
- Analysis ID
- c11231057bf31635afa5a7f487650347
- Customs Code
- DHA05603327907
Company information
- Manufacturer
- CEPHEID AB
- Manufacturer Country
- Sweden
- Authorized Representative
- PROGRESSIVE GROUP INC.
Product details
- Intended Use
- This product is an in vitro diagnostic reagent for polymerase chain chain reaction, which is used with the automatic GeneXpert Dx instrument system to quantitatively detect the content of hepatitis B virus (HBV) DNA in serum or plasma (EDTA) of patients with chronic hepatitis B infection.
- Product Type (Level 1)
- B Hematology, pathology, and genetics
- Product Type (Level 2)
- B.4020 Analysis of specific tests
- Import Information
- import
Dates and status
- Registration Date
- Feb 20, 2020
- Expiry Date
- Feb 20, 2030
About this record
Access comprehensive regulatory information for Espert hepatitis B virus detection kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number c11231057bf31635afa5a7f487650347 and manufactured by CEPHEID AB. The authorized representative in Taiwan is PROGRESSIVE GROUP INC..
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