Lipase (Colorimetric)

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

6 warnings recorded — scroll inside the panel to see all entries.

• CW011

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• CW085

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• CW167

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• CW416

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Primary placement in Finland; available across 28 countries total.

Trade name

Lipase (Colorimetric)

UDI-DI code

16438153818462

Basic UDI-DI

6438153BU00162BU

Reference / catalog number

981846

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 lipase (EC 3.1.1.3; triacylglycerol acylhydrolase) activity in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The lipase test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of pancreatic disorders, such as acute pancreatitis, chronic pancreatitis and obstruction of the pancreatic duct, in patients.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01010123LIPASE

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

Certificate health across this manufacturer's portfolio.