Alkaline Phosphatase (IFCC) Plus

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

Primary placement in Finland; available across 28 countries total.

Trade name

Alkaline Phosphatase (IFCC) Plus

UDI-DI code

16438153818325

Basic UDI-DI

6438153BU00156BZ

Reference / catalog number

981832

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 alkaline phosphatase (orthophosphoric – monoester phospho-hydrolase, alkaline optimum, EC 3.1.3.1) activity in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Alkaline Phosphatase test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of hepatobiliary diseases, such as cholestasis, tumors, inflammation or infectious hepatitis, in patients. Furthermore, the Alkaline Phosphatase test in indicated to be used in conjunction with clinical evaluation as an aid to diagnosis and monitoring of bone diseases associated with increased osteoblastic activity, in patients.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01010105ALKALINE PHOSPHATASE - TOTAL

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