0009802044

Organization name

Biokit S.A.

SRN

ES-MF-000002406

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW266

  EUDAMED did not publish a description for this code.
• CW267

  EUDAMED did not publish a description for this code.
• CW999

  This product contains less than 0.1% sodium azide that may form explosive azides in metal plumbing. Use proper disposal procedures.
• CW999

  Microparticles Reagent: Up to 3.0% of the mixture consists of component of unknown acute toxicity (inhalation) for the human health.
• CW999

  Assay Buffer, Tracer: Up to 2.9% of the mixture consists of component of unknown acute toxicity (inhalation) for the human health.
• CW999

  VWF:CB Calibrator 2: ≈ 100% of the mixture consists of component of unknown acute toxicity (oral, dermal, inhalation) for the human health and unknown toxicity to the aquatic environment.

Primary placement in Spain; available across 5 countries total.

Trade name

not provided

UDI-DI code

08426950925743

Basic UDI-DI

84269509257439V

Reference / catalog number

0009802044

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

HemosIL AcuStar VWF:CB

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0103020218COAGULATION FACTOR VON WILLEBRAND COLLAGEN BINDING ASSAY (CBA)

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