Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
PaxView HPV16/HPV18 MPCR-ULFA Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
4
Notified Bodies
0
Basic Information
- Primary DI
- 08800097500016
- Basic UDI-DI Code
- B-08800097500016
- Reference
- V0330
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- PaxGenBio Co., Ltd.
Additional Description
PaxView® HPV16/18 MPCR-ULFA Kit includes Component 1. MPCR Kit and Component 2. ULFA Kit. MPCR Kit is composed of reagents filled in a 1.5ml polypropylene tube with a HDPE cap. The reagents consist in POSITIVE CONTROL, 2X PCR PREMIX and PRIMER MIX. ULFA Kit is composed of reagents (RUNNING BUFFER and WASHING BUFFER) filled in a 5ml screw-cap tube, and ULFA DEVICE contained in a sealed silver foil pouch with desiccant.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105041003 | PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS |
Available In Countries
🇨🇿 Czechia
🇬🇷 Greece
🇮🇹 Italy
🇵🇱 Poland
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