BioIC Allergen Specific-IgE Detection Kit

Primary DI

04719892991155

Basic UDI-DI Code

471989299Allergy8G

Reference

AP40

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

AGNITIO SCIENCE &TECHNOLOGY,INC.

The BioIC™ Allergen Specific-IgE Detection Kit is used with Agnitio BioIC™ Analyzer for in vitro diagnosis of patients with allergic sensitization to multiple different allergens. It is a human, allergen-specific IgE, semi-quantitative assay. The severity of the allergy during the test period is indicated by reaction class designation according to the amount of specific IgE present in a human serum sample.

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