Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Human Papillomavirus Nucleic Acid Amplification Test Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06970895475501
- Basic UDI-DI Code
- B-06970895475501
- Reference
- S01402T2024
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
Additional Description
This kit is intended to qualitatively detect the deoxyribonucleic acid (DNA) of 24 types of human papillomavirus (HPV) in women's cervical shedding cell samples,and identify HPV as 16, 18 ,31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 26, 53, 66, 73,82, 6, 11, 42, 43, 44 or 81 genotypes. It is used for assisted diagnosis of HPV infection. For professional in-vitro diagnostic use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105041004 | FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS |
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