ASSAYED MULTICOMPONENT CONTROLS (CC)

Primary DI

06935740733748

Basic UDI-DI Code

69357404ICAS00003686

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 compound quality control products for biochemical immunity is intended to be used for the quality control of biochemical reagent on Automatic Chemistry Analyzer. For the internal quality control of biochemical analysis items following in clinical laboratory: 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), apolipoprotein A1 (Apo A1), apolipoprotein B (Apo B), Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), complement C3 (C3), complement C4 (C4), transferrin (TF), β2-microglobulin (β2-MG), prealbumin (PA), 43 items in total.

The Basic UDI-DI associated with this device has 4 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).