Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
LyoHarmonyHPV Test
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06971042225277
- Basic UDI-DI Code
- B-06971042225277
- Reference
- LTD-0557-02-96
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- SHANGHAI ZJ BIO-TECH CO., LTD
Additional Description
LyoHarmonyHPV Test is a single-use qualitative in vitro test for the detection of DNA from 12 high risk human papillomavirus (HPV) genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58 and 59 in patient cervical specimens with Automated Workstation for Nucleic Acid Extraction and PCR Test (AutraMic mini4800 Plus) to realize automatic sample detection, including extraction, purification, amplification, detection procedures.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105041003 | PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS |
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