LDH (IFCC)

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

Primary placement in Finland; available across 28 countries total.

Trade name

LDH (IFCC)

UDI-DI code

16438153004384

Basic UDI-DI

6438153BU00180BW

Reference / catalog number

981906

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 LDH (L-Lactate: NAD oxidoreductase EC 1.1.1.27) activity in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The LDH (IFCC) test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of variety of diseases, including hematological and oncological diseases, such as hemolytic anemia and leukemia, in patients. Furthermore, the LDH (IFCC) test is indicated to be used for assessing the degree of cell destruction in diseases of liver, cardiac- and skeletal muscles, kidney and lungs, in patients.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01010119LACTATE DEHYDROGENASE L ( LDH - L --> P )

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