CK-MB

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

  EUDAMED did not publish a description for this code.
• CW096

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• CW138

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• CW167

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• CW313

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• CW265

  imidazole

Primary placement in Finland; available across 28 countries total.

Trade name

CK-MB

UDI-DI code

16438153818349

Basic UDI-DI

6438153BU00052BL

Reference / catalog number

981834

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 CK-MB (B subunit of the isoenzyme CK-MB of creatine kinase, ATP: Creatine N-Phosphotransferase (CK), EC 2.7.3.2) activity in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The CK-MB test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis of heart injury and skeletal muscle damage, in patients.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01010114CREATINE KINASE - MB ACTIVITY (CC)

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

Certificate health across this manufacturer's portfolio.