Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)

Changsha Sinocare Inc. · 🇨🇳 China
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
D-02B0021YH
Basic UDI-DI Code
B-02B0021YH
Reference
2M001
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market
Manufacturer
Changsha Sinocare Inc.

Additional Description

NGAL Reagent Kit is intended to quantitatively determine the content of NGAL in human plasma in vitro. Clinically, it is mainly used for the auxiliary diagnosis of early acute kidney injury (AKI). NGAL serves as a biomarker in renal injury and function at the early stage. When AKI is diagnosed in the early stage, the concentration of NGAL usually increases rapidly in blood and urine, which is the most obvious within 2 hours. It can be used to determine AKI in patients with ischemic renal injury, sepsis, heart surgery and the response of intravenous X-ray contrast agent.

CND Nomenclature Codes

Code Description
W0102060207 NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)

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