Total Protein Plus

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

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• CW011

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• CW073

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Primary placement in Finland; available across 28 countries total.

Trade name

Total Protein Plus

UDI-DI code

16438153818271

Basic UDI-DI

6438153BU00184C6

Reference / catalog number

981827

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 total protein concentration in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Total Protein Plus test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of hypo- and hyperproteinemia of various reasons, in patients. They may include changes in the plasma volume of water (overhydration or dehydration), increase or decrease of protein synthesis or protein loss as well as due to various diseases of liver, kidney and bone marrow. Hypo- and hyperproteinemia may also occur due to infections, gastro-intestinal-, metabolic- or endocrinological diseases.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01010230TOTAL PROTEIN

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

Certificate health across this manufacturer's portfolio.