D-Dimer Control High

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

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

• CW263

  EUDAMED did not publish a description for this code.
• CW129

  Contains 2-chloracetamid

Primary placement in Finland; available across 28 countries total.

Trade name

D-Dimer Control High

UDI-DI code

16438153003240

Basic UDI-DI

6438153BU00066BX

Reference / catalog number

981869

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

D-Dimer Control High is used as a precision control of in vitro diagnostic tests for the determination of D-Dimer concentration in human samples with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0103020702CONTROL PLASMA FOR HAEMOSTASIS

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

Certificate health across this manufacturer's portfolio.