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"Kaijie" second-generation high-risk human papillomavirus deoxyribonucleic acid qualitative amplification test - Taiwan Registration 5f1a4cc85d34a4bee602fc31a184bcf5

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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5f1a4cc85d34a4bee602fc31a184bcf5
Registration Details
Taiwan FDA Registration: 5f1a4cc85d34a4bee602fc31a184bcf5
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Device Details

"Kaijie" second-generation high-risk human papillomavirus deoxyribonucleic acid qualitative amplification test
TW: โ€œๅ‡ฑๆฐโ€็ฌฌไบŒไปฃ้ซ˜ๅฑ้šชๅž‹ไบบ้กžไนณ็ช็˜ค็—…ๆฏ’ๅŽปๆฐงๆ ธ้†ฃๆ ธ้…ธๅฎšๆ€งๆ“ดๅขž่ฉฆ้ฉ—
Risk Class 3

Registration Details

5f1a4cc85d34a4bee602fc31a184bcf5

DHA00602430705

Company Information

United States

Product Details

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.

C Immunology and microbiology

C.0004 Human papillomavirus serum reagent

import

Dates and Status

Dec 27, 2012

Dec 27, 2027