Multiple clinical chemistry constituent IVDs

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

זמין מ:

HYP Investment Pty Ltd

סיווג:

Class 2

תוצרת:

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

איזור תרפויטי:

CT889 - Multiple clinical chemistry constituent IVDs

סממני תרפויטית:

The products under this registration are multi control kits to be used on immunoassay analyzers to ensure the instrument and respective reagent kit are functioning as intended and performing optimally. The products are to be used in a laboratory setting and operated by professionally trained staff. The results generated by the control kits are NOT for diagnostic purpose and it is only to be used by laboratory staff to determine the performance of the instrument and the targeting reagent kit(s). The products also consist of reagent kits with multiple testing parameters, these kits are to be used on immunoassay analyzers to detect the presence and determine the concentration of multiple substance including, but are not exclusive to, specific proteins, hormones and antigens. These 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.

מצב אישור:

A

תאריך אישור:

2018-05-17