Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Human Papillomavirus Nucleic Acid Detection and HPV16/18 Genotyping Kit (PCR-Fluorescence Probing)
Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- 06955931302867
- Basic UDI-DI Code
- B-06955931302867
- Reference
- 2116DF
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Yaneng BIOscience (Shenzhen) Co., Ltd.
Additional Description
This kit is a qualitative in vitro test for the detection of human papillomavirus (HPV) in cervical exfoliated epithelial cells specimens. The test not only applies to detect 18 high-risk (HR) HPV types , including type 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82, but also can identify the specific types of HPV16 and HPV18 simultaneously. The kit is “For Professional Use Only” by trained and validated laboratory personnel.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105041003 | PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS |
Available In Countries
🇮🇹 Italy
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