CRP

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW267

  EUDAMED did not publish a description for this code.

Primary placement in Finland; available across 28 countries total.

Trade name

CRP

UDI-DI code

16438153816994

Basic UDI-DI

6438153BU00102BA

Reference / catalog number

981699

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

For in vitro diagnostic use in the quantitative determination of C-reactive protein (CRP) concentration in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The CRP test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of infections and systemic inflammatory processes and diseases, such as invasive bacterial infections and extensive tissue damage, in patients. Furthermore, the CRP test is indicated to be used in conjunction with clinical evaluation for monitoring the activity of disease and patient’s response to treatment and antibiotics during a bacterial infection, and after surgery for aid to diagnosis and monitoring of complications, 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.