HPV REAGENTS - OTHER
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Basic Information
- Primary DI
- 08800204300669
- Basic UDI-DI Code
- B-08800204300669
- Reference
- RS002
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- KH Medical Co., Ltd.
Additional Description
The RADI HUMAN PAPILLOMAVIRUS Detection KIT is an in vitro diagnostic medical device, based on Real-time RT-PCR technology to screen the HUMAN PAPILLOMAVIRUS DNA. The kit is intended for the presumptive qualitative screening of nucleic acid extracted from the 2 High risk HUMAN PAPILLOMAVIRUS 16 (HEX) and HUMAN PAPILLOMAVIRUS18 (ROX) and the other comparative low risk genotypes (HUMAN PAPILLOMAVIRUS 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68-FAM) in human urine and vaginal swab specimen. The assay is for use by a laboratory professional trained to use real-time PCR in a laboratory.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105041099 | HPV REAGENTS - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).