Rheumatoid Factors 2 (RF 2)

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

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Primary placement in Finland; available across 28 countries total.

Trade name

Rheumatoid Factors 2 (RF 2)

UDI-DI code

16438153819209

Basic UDI-DI

6438153BU00166C4

Reference / catalog number

981920

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 Rheumatoid factors concentration in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Rheumatoid Factors 2 (RF2) test is indicated to be used in conjunction with clinical evaluation for aid to prognosis of aggressive form of rheumatoid arthritis (RA), in patients.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01021110RHEUMATOID FACTORS

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

Certificate health across this manufacturer's portfolio.