Taiwan FDA registration 4bdbf74b0b5229160ed7501f446fd96d
Xpert HIV-1 Viral Load
TW: 艾斯柏特人類免疫缺陷病毒檢測試劑組
Taiwan·Risk Class 3·MD·CEPHEID AB·Registered Oct 22, 2018 – Oct 22, 2028ActiveRegistration details
- Analysis ID
- 4bdbf74b0b5229160ed7501f446fd96d
- License Form
- Ministry of Health Medical Device Import No. 031746
- Customs Code
- DHA05603174602
Company information
- Manufacturer
- CEPHEID AB
- Manufacturer Country
- Sweden
- Authorized Representative
- PROGRESSIVE GROUP INC.
Product details
- Intended Use
- This product is a reverse transcription polymerase chain reaction (RT-PCR) in vitro diagnostic reagent for the quantification of human immunodeficiency virus type 1 (HIV-1), and HIV-1 RNA in the plasma of infected patients is performed with a fully automated GeneXpert instrument system. This product can be used to quantify HIV-1 M types (subtypes A, B, C, D, E, F, G, H, I, J, K, CRF01_AE, CRF02_AG and CRF03_AB), N and O types, and can quantify HIV-1 RNA from 40 to 10,000,000 copies/ml.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B4020 Analyze specific reagents
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Oct 22, 2018
- Expiry Date
- Oct 22, 2028
About this record
Access comprehensive regulatory information for Xpert HIV-1 Viral Load in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 4bdbf74b0b5229160ed7501f446fd96d and manufactured by CEPHEID AB. The authorized representative in Taiwan is PROGRESSIVE GROUP INC..
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