Bacterial infectious disease IVDs

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Доступно од:

HYP Investment Pty Ltd

Класа:

Class 2

Произведен од:

Shenzhen YHLO Biotech Co Ltd Building 1 YHLO Biopark Baolong 2nd Road Baolong Subdistrict, Longang District, Shenzhen, 518116 China

Терапеутска област:

CT353 - Bacterial infectious disease IVDs

Терапеутске индикације:

The products under this registration are reagent kits intended to be used on immunoassay analyzers to detect the presence and determine the concentration of various bacterial antigens in a given sample for diagnostics purpose. The products are to be used in a laboratory setting and operated by professionally trained staff. The results generated by these reagent kits are to be interpret by professionally trained physicians or general practitioners.

Статус ауторизације:

A

Датум одобрења:

2018-05-04