sthemA HB-250

Organization name

Tcoag ireland ltd

SRN

IE-MF-000027371

Manufacturer status

Active

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

• CW166

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

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• CW422

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• CW085

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• CW103

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• CW082

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• CW076

  EUDAMED did not publish a description for this code.

Primary placement in France; available across 5 countries total.

Trade name

sthemA HB-250

UDI-DI code

05391521421807

Basic UDI-DI

53915214HB2509X

Reference / catalog number

01405

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 HB-250 is an erythrocytes lysis agent which allows the quantitative determination of hemoglobin on sthemA 600 and sthemA 800 series analyzers. The sthemA HB-250 comes in a box containing six 250 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