URIT-1600 Automatic Urine Analyzer

Primary DI

06935740723497

Basic UDI-DI Code

69357404IUC000001U4

Reference

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Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

URIT Medical Electronic Co.,Ltd.

The Automatic Urine Analyzer is intended for use in conjunction with the reagent strips produced by URIT Medical Electronic Co., Ltd. for the semi-quantitative or qualitative detection of various biochemical analytes in urine samples, including Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Blood (BLD), Protein (PRO), Nitrite (NIT), Leukocytes (LEU), Glucose (GLU), Specific Gravity (SG), pH, Vitamin C (VC), Microalbumin (MA), Creatinine (CR) and Calcium (Ca). In addition, the Automatic Urine Analyzer has two other optional function: urine color measurement and urine turbidity measurement. The subject device is intended for professional in vitro diagnostic use only. Measurements of the Automatic Urine Analyzer can be used in general evaluation of health and provide reference for clinical examination and diagnosis.

The Basic UDI-DI associated with this device has 3 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 A) and regulation (EU IVDR).