Taiwan FDA registration 5f1a4cc85d34a4bee602fc31a184bcf5
"Kaijie" second-generation high-risk human papillomavirus deoxyribonucleic acid qualitative amplification test
TW: “凱杰”第二代高危險型人類乳突瘤病毒去氧核醣核酸定性擴增試驗
Taiwan·Risk Class 3·QIAGEN·Registered Dec 27, 2012 – Dec 27, 2027ActiveRegistration details
- Analysis ID
- 5f1a4cc85d34a4bee602fc31a184bcf5
- Customs Code
- DHA00602430705
Company information
- Manufacturer
- QIAGEN
- Manufacturer Country
- United States
- Authorized Representative
- QIAGEN TAIWAN COMPANY LIMITED
Product details
- Intended Use
- The hc2 High-Risk HPV DNA Assay Kit with Hybrid Capture 2 (hc2) technology is a nucleic acid hybridization assay that uses microplate chemiluminescence for signal amplification to qualitatively detect 13 high-risk human neoviruses (HPV16/18/31/33/35/35/39/45/51/52/56/58/59/68) DNA in cervical samples.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.0004 Human papillomavirus serum reagent
- Import Information
- import
Dates and status
- Registration Date
- Dec 27, 2012
- Expiry Date
- Dec 27, 2027
About this record
Access comprehensive regulatory information for "Kaijie" second-generation high-risk human papillomavirus deoxyribonucleic acid qualitative amplification test in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 5f1a4cc85d34a4bee602fc31a184bcf5 and manufactured by QIAGEN. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.
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