CONTROL POSITIVO EN SECO ROTA-ADENO-NORO || DRY POSITIVE CONTROL ROTA-ADENO-NORO

Primary DI

08429577003481

Basic UDI-DI Code

8429577905012CH

Reference

9.050.011.12.000

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

OPERON, S.A.

A positive control to check that the following tests work and occur correctly: Simple-Stick Rotavirus, Simple-Stick Rota-Adeno, Simple-Stick Norovirus, Simple Rota-Adeno-Noro. For professional use only. The user needs to have basic sampling and laboratory technique knowledge. The product consists of a swab containing a dried preparation of a mix of purified Rotavirus and Adenovirus viral proteins and recombinant virus-like particles (non-infectious) belonging to Norovirus GI.1 (Norwalk) and GII.4 (MD145) genotypes, all diluted in a stabilised buffered solution. It is a quality control for the aforementioned products to check that the detection process occurs correctly. This product is exclusively for in vitro diagnostic use.

Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).