IGF-1 CLIA Microparticles

Primary DI

06970150908904

Basic UDI-DI Code

697015090000039HB

Reference

CML0102

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Autobio Diagnostics Co., Ltd.

The IGF-1 CLIA Microparticles assay and AutoLumo IGF-1 Calibrators are used together based on the fully automated chemiluminescent microparticle immunoassay (CLIA Microparticles) system for the quantitative determination of Insulin-like Growth Factor I (IGF-I) concentration in human serum and plasma (Heparin). Clinical determination of IGF-1 is used as an aid 1) as an auxiliary evaluation index for growth disorder; 2) to diagnosis of GH deficiency and overdose; 3) as an indicator of whether the treatment of gigantism and acromegaly is effective.

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).