Renin CLIA Microparticles

Primary DI

06970150908539

Basic UDI-DI Code

697015090000021GQ

Reference

CMD0402

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Autobio Diagnostics Co., Ltd.

The Renin CLIA Microparticles assay and AutoLumo Renin Calibrators are used together based on the fully automated chemiluminescent microparticle immunoassay (CLIA Microparticles) system for the quantitative determination of Renin in human plasma (EDTA). Clinical determination of Renin is used as an aid 1) to diagnosis of hypertension or renovascular hypertension due to renal artery stenosis; 2) to assist the clinician in deciding whether to conduct renal vascular imaging studies; 3) to diagnosis of primary aldosteronism; 4) to provide effective information for the occurrence of complications of cardiovascular system in patients with essential hypertension.

The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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