U/CSF Protein

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

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• CW100

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• CW158

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• CW265

  Methanol

Primary placement in Finland; available across 28 countries total.

Trade name

U/CSF Protein

UDI-DI code

16438153818431

Basic UDI-DI

6438153BU00057BW

Reference / catalog number

981843

Issuing entity

GS1

Risk category

IVDR Class C

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 the total protein concentration in human urine and cerebrospinal fluid with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The urine protein test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of renal or pre-renal proteinuria, in patients. The cerebrospinal fluid (CSF) protein test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis of hyperproteinemia, due to various neurological diseases, where total CSF protein levels are increased, in patients.

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

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