LISTERIA DETECTION BY NA REAGENTS

Primary DI

06974858560860

Basic UDI-DI Code

B-06974858560860

Reference

P579H

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Suzhou TianLong Biotechnology Co., Ltd.

The test is designed to detect DNA from Listeria monocytogenes in specimens such as human rectal swab sample or human stool sample. The potential candidate personnel to be tested could include, but are not limited to patients with symptoms of infection who are suspected of listeriosis by healthcare providers, or persons with no symptoms from a population for screening test confirmation or exclusion of listeriosis infection or Listeria monocytogenes carriage status.

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