Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
High-Risk Human Papillomavirus ( HPV) and Genotyping 16&18 Diagnostic Kit(PCR-Fluorescence)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06971042228636
- Basic UDI-DI Code
- B-06971042228636
- Reference
- TD-0413-02-100
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- SHANGHAI ZJ BIO-TECH CO., LTD
Additional Description
High-Risk Human Papillomavirus (HPV) and Genotyping 16&18 Diagnostic Kit(PCR-Fluorescence) is used for the detection of 14 HPV viruses to support the diagnosis of HPV-caused cervix cancer. Using fluorescent PCR detective method, this kit can detect specific DNA fragments of HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 in secretion of urogenital tract and in cervical cells. Among them, HPV subtypes 16 and 18 are detected separately.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105041003 | PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS |
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