Albumin MST

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

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• CW267

  EUDAMED did not publish a description for this code.

Primary placement in Finland; available across 28 countries total.

Trade name

Albumin MST

UDI-DI code

16438153819278

Basic UDI-DI

6438153BU00152BR

Reference / catalog number

981927

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 low albumin concentration in human urine with the automated procedure of Thermo Scientific™ Indiko™ and Konelab™ analyzers, and for the quantitative determination of albumin concentration in human serum and plasma with the automated procedures of Thermo Scientific™ Konelab™ analyzer. The urine Albumin MST test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of albuminuria, caused by renal damage due to e.g. diabetes, hypertension, minor glomerulus lesion or inhibition of reabsorption, in patients. The urine Albumin MST test is furthermore indicated to be used in conjunction with clinical evaluation for aid to early diagnosis and predicting of diabetic nephropathy and end-stage renal disease, in patients. The serum and plasma Albumin MST test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of a multitude of clinical conditions correlating with decreased albumin levels, such as hepatic- and renal functional status, nutritional- and fluid balance and inflammation, in patients. Furthermore, the serum and plasma Albumin MST test is indicated be used in conjunction with clinical evaluation for aid to diagnosis of analbuminemia, in patients.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102010309ALBUMIN (IC) INCL. UALBUMIN

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