04R4616

Organization name

Biokit S.A.

SRN

ES-MF-000002406

Manufacturer status

Active

5 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.
• CW011

  This product contains human-sourced and/ or potentially infectious components. Refer to the CONTENTS section of this package insert. No known test method can offer complete assurance that products derived from human sources or inactivated microorganisms will not transmit infection. Therefore, all human-sourced materials should be considered potentially infectious. It is recommended that this product, human specimens, and all consumables contaminated with potentially infectious materials be handled in accordance with the OSHA Standard on Bloodborne Pathogens. Biosafety Level 2 or other appropriate regional, national, and institutional biosafety practices should be used for materials that contain, are suspected of containing, or are contaminated with infectious agents.
• CW116

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

  Contains sodium azide.

Primary placement in Spain; available across 1 country total.

Trade name

not provided

UDI-DI code

00380740175443

Basic UDI-DI

8436003070641XL

Reference / catalog number

04R4616

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

Alinity c Ferritin/Myoglobin/IgE Control Kit

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102152003SPECIFIC PROTEIN CONTROLS

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