BioCLIA Allergy Reagent Kit, Mx1

Primary DI

06924030413316

Basic UDI-DI Code

B-06924030413316

Reference

MY01692

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

HOB Biotech Group Corp., Ltd.

BioCLIA Allergy Reagent Kit, Mx1 is an in vitro qualitative assay for the determination of specific IgE to Penicillium chrysogenum (m1), Cladosporium herbarum (m2), Aspergillus fumigatus (m3), Alternaria alternata (m6) in human serum via chemiluminescent immunoassay method on the fully automatic BioCLIA instrument. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders specific to M1, M2, M3, M6 in conjunction with other clinical findings, and is to be used in clinical laboratories.

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