Sodium Micro Volume Electrode

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

Primary placement in Finland; available across 28 countries total.

Trade name

Sodium Micro Volume Electrode

UDI-DI code

16438153815942

Basic UDI-DI

6438153BU00146BW

Reference / catalog number

981594

Issuing entity

GS1

Risk category

IVDR Class B

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

INTENDED PURPOSE / INTENDED USE For in vitro diagnostic use in the quantitative determination of sodium concentration in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ analyzers, and in human serum, plasma and urine with the automated procedures of Thermo Scientific™ Konelab™ analyzers. The Sodium Micro Volume Electrode test is indicated to be used in conjunction with clinical evaluation for screening and monitoring of disturbances in sodium homeostasis and water and acid-base balance as a part of basic metabolic panel, in patients. Decreased serum sodium levels (hyponatremia) can be due to decreased sodium intake or loss of sodium from gastrointestinal tract (vomiting, diarrhea), kidneys or sweat glands. Increased serum sodium levels (hypernatremia) can be due to e.g. dehydration, liver, renal and adrenal diseases, or polyuria, in patients. The Sodium Micro Volume Electrode urine test is indicated to be used in conjunction with clinical evaluation for monitoring of kidney function to complement the plasma sodium analysis, in patients.

Additional information URL

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Clinical sizes

No clinical sizes registered for this device.

• W0101070107SODIUM - ELECTRODES

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