sthemA CL-250

Organization name

Tcoag ireland ltd

SRN

IE-MF-000027371

Manufacturer status

Active

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

• CW008

  The reagent provided in this kit contains materials of human and/or animal origin. Whenever human plasma is required for the preparation of this reagent approved methods are used to test the plasma for the antibodies to HIV 1, HIV 2 and HCV, and for hepatitis B surface antigen, and results are found to be negative. However, no test method can offer complete assurance that infectious agents are absent. Therefore, users of this reagent must exercise extreme care in full compliance with safety precautions in the manipulation of these biological materials as if they were infectious.
• CW011

  The sthemA CL-250 reagent contains potassium hydroxide, a corrosive chemical at the concentration provided (< 1 %).
• CW081

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

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

  EUDAMED did not publish a description for this code.
• CW444

  EUDAMED did not publish a description for this code.
• CW430

  EUDAMED did not publish a description for this code.
• CW416

  EUDAMED did not publish a description for this code.
• CW397

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

  EUDAMED did not publish a description for this code.

Primary placement in France; available across 11 countries total.

Trade name

sthemA CL-250

UDI-DI code

05391521421999

Basic UDI-DI

53915214CL250AE

Reference / catalog number

01424

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 CL-250 is a decontaminating solution for cleaning use on sthemA 800 series analyzers. The sthemA CL-250 comes in a box containing 4 x 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