Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

ELECTROLYTES - OTHER

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

Basic Information

Primary DI
D-02B0018YU
Basic UDI-DI Code
B-02B0018YU
Reference
2Z001
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market
Manufacturer
Changsha Sinocare Inc.

Additional Description

The Electrolyte (CO2/Mg/P/Fe) Reagent Kit is intended to quantitatively determine CO2, Mg, P, or Fe in human serum. Clinically, it is mainly used for auxiliary diagnosis of electrolyte balance. The concentration of carbon dioxide (CO2) exerts important function on evaluation of the acid-base balance in the blood. The decrease in CO2 is observed in the compensation of metabolic acidosis or respiratory alkalosis, while its increase is seen in the compensation of metabolic alkalosis or respiratory acidosis. Magnesium (Mg) is a cofactor of many intracellular enzymes, including all enzymes with ATP as substrate, so it is helpful to maintain normal metabolism for human. Hypomagnesemia may result in an increase in neuromuscular and heart excitability, while hypermagnesemia can antagonize the transmission of nerve impulse, resulting in muscle weakness. Many diseases are accompanied by abnormal magnesium metabolism. For instance, renal insufficiency, uremia, oxalate poisoning, arthritis and severe dehydration can contribute to the increase in blood magnesium, whereas malabsorption, diabetes, acidosis coma, hyperthyroidism, and acute pancreatitis are contributing factors for reduced blood magnesium. The increase in inorganic phosphorus (P) in serum is commonly seen in hypoparathyroidism, renal insufficiency or late stage nephritis, excessive vitamin D, fracture healing and etc., while its decrease is observed in hyperparathyroidism, increased glucose utilization, renal tubular degeneration and other diseases. The rise in serum iron (Fe) is commonly seen in erythrocyte destruction, dysfunction on erythrocyte regeneration or maturation, and hematopoietic dysfunction caused by lead poisoning or vitamin B6 deficiency, etc., while its decrease is accompanied by in insufficient intake of Fe, intake of aspirin, colenemide and other drugs, acute and chronic infection, uremia and etc.

CND Nomenclature Codes

Code Description
W01010399 ELECTROLYTES - OTHER
W01010307 PHOSPHATE INORGANIC / PHOSPHORUS
W01010306 MAGNESIUM
W0101060601 CARBON DIOXIDE - ELECTRODES (BG)

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