The DNA testing kit for the detection and differentiation of 14 types of high-risk human papilloma virus (HPV) - Vietnam Registration 230000348/PCBB-BYT
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Device Details
Registration Details
230000348/PCBB-BYT
000.00.04.G18-231014-0002
High Risk HPV ELITe Panel
Technical Details
The "High Risk HPV ELITe Panel" product is a multiplex nucleic acid amplification real-time test designed to qualitatively detect and differentiate the DNA of 14 types of high-risk human papillomavirus (HPV) that cause cervical cancer in samples of DNA extracted from cervical cytology samples. The test specifically identifies types HPV16 and HPV18 and simultaneously detects the remaining high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68). This product is intended to be used as an in vitro diagnostic tool to support the diagnosis of HPV infection, in conjunction with the patient's clinical data and other laboratory test results.
Dates and Status
Oct 14, 2023