Amylase (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

Amylase (IFCC)

UDI-DI code

16438153005220

Basic UDI-DI

6438153BU00061BM

Reference / catalog number

981950

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 α-amylase (1,4-α-D-glucan glucanohydrolase, EC 3.2.1.1) activity in human serum, plasma and urine with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Amylase test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of diseases of the pancreas, such as acute pancreatitis, in patients. Furthermore, the Amylase test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis of other clinical disorders, which are not specific to pancreatitis, such as salivary gland inflammation, acute intra-abdominal disorders or genitourinary diseases, in patients. For in vitro diagnostic use in the quantitative determination of the α-amylase (1,4-α-D-glucan glucanohydrolase, EC 3.2.1.1) activity in human serum, plasma and urine with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Amylase test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of diseases of the pancreas, such as acute pancreatitis, in patients. Furthermore, the Amylase test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis of other clinical disorders, which are not specific to pancreatitis, such as salivary gland inflammation, acute intra-abdominal disorders or genitourinary diseases, in patients.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01010107AMYLASE - TOTAL

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