sthemA FL-50

Organization name

Tcoag ireland ltd

SRN

IE-MF-000027371

Manufacturer status

Active

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

• CW083

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

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

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

  EUDAMED did not publish a description for this code.
• CW422

  EUDAMED did not publish a description for this code.
• CW075

  EUDAMED did not publish a description for this code.
• CW079

  EUDAMED did not publish a description for this code.
• CW087

  EUDAMED did not publish a description for this code.
• CW081

  EUDAMED did not publish a description for this code.
• CW103

  EUDAMED did not publish a description for this code.
• CW104

  EUDAMED did not publish a description for this code.
• CW082

  EUDAMED did not publish a description for this code.
• CW084

  EUDAMED did not publish a description for this code.
• CW085

  EUDAMED did not publish a description for this code.

Primary placement in France; available across 5 countries total.

Trade name

sthemA FL-50

UDI-DI code

05391521421791

Basic UDI-DI

53915214FL50JZ

Reference / catalog number

01422

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The sthemA FL-50 is a dye solution used for blood cell populations count on sthemA 600 series analyzers. The sthemA FL-50 comes in a box containing eight 50 mL bottles.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0103010105CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

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