CALIBRATORS MULTICOMPONENT (CC)

Primary DI

06935740733694

Basic UDI-DI Code

69357404ICAS00003482

Reference

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Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

URIT Medical Electronic Co.,Ltd.

Multiple biochemical calibrators is intended to be used for the calibration of biochemical reagent on Automatic Chemistry Analyzer. For the calibration of biochemical analysis items in clinical laboratory as follows: Albumin (ALB), alanine aminotransferase (ALT), alpha-amylase (α-AMY), aspartate aminotransferase (AST), carbon dioxide (CO2), total bile acid (TBA), total bilirubin (TB), direct bilirubin (DB), calcium (Ca), cholesterol (CHOL), creatinine kinase (CK), creatinine (CR), γ-glutamyltransferase (GGT), glucose (Glu), Iron (Fe), magnesium (Mg), total protein (TP), triglyceride (TG), urea (Urea), uric acid (UA), alkaline phosphatase (ALP), cholinesterase (CHE), α-hydroxybutyrate dehydrogenase (α-HBDH), lactate dehydrogenase (LDH) Inorganic phosphorus (P), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), lipase (LPS), pancreatic amylase (PAMY), sialic acid (SA), lactic acid (LAC), β-hydroxybutyric acid (D3H), leucine aminopeptidase (LAP), 33 items in total.

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).