PaxView HPV20 Genotyping MPCR-ULFA Kit

Primary DI

08800097500047

Basic UDI-DI Code

B-08800097500047

Reference

V0324

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

PaxGenBio Co., Ltd.

A complete set of PaxView® HPV20 Genotyping MPCR-ULFA Kit includes 2 panels ([Panel. 1] and [Panel. 2]). Each panel comprises two (2) components: Component 1. MPCR Kit and Component 2. ULFA Kit. MPCR Kits are 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 Kits are composed of reagents (RUNNING BUFFER and WASHING BUFFER) filled in a 5ml screw-cap tube, and ULFA DEVICE or cartridge according to the variant, contained in a sealed silver foil pouch with desiccant. There are either 24, 48 or 96 tests / 1 kit.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).