Albumin (BCG)

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

Primary placement in Finland; available across 28 countries total.

Trade name

Albumin (BCG)

UDI-DI code

16438153817670

Basic UDI-DI

6438153BU00151BP

Reference / catalog number

981767

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 albumin concentration in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Albumin (BCG) 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 Albumin (BCG) 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.

• W01010201ALBUMIN (CC)

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

Certificate health across this manufacturer's portfolio.