CRP High Sensitivity

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

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

• CW011

  EUDAMED did not publish a description for this code.
• CW263

  EUDAMED did not publish a description for this code.
• CW076

  EUDAMED did not publish a description for this code.
• CW106

  EUDAMED did not publish a description for this code.
• CW116

  EUDAMED did not publish a description for this code.
• CW159

  EUDAMED did not publish a description for this code.
• CW167

  EUDAMED did not publish a description for this code.
• CW296

  EUDAMED did not publish a description for this code.
• CW166

  EUDAMED did not publish a description for this code.

Primary placement in Finland; available across 28 countries total.

Trade name

CRP High Sensitivity

UDI-DI code

16438153817984

Basic UDI-DI

6438153BU00060BK

Reference / catalog number

981798

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

For in vitro diagnostic use in the quantitative determination of low concentrations of C-reactive protein (CRP) in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The CRP High Sensitivity test is indicated to be used in conjunction with clinical evaluation as an aid for prediction and monitoring the risk of cardiovascular diseases and disorders, such as myocardial infarction, stroke, peripheral vascular disease and sudden cardiac death, in patients. Additionally, the CRP High Sensitivity test is also used in conjunction with clinical evaluation as an aid in the prediction of the risk for future metabolic syndrome, diabetes and hypertension, in patients.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01021109C-REACTIVE PROTEIN

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

Certificate health across this manufacturer's portfolio.