Quantia PROTEINS Standard

Organization name

Biokit S.A.

SRN

ES-MF-000002406

Manufacturer status

Active

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

• CW266

  EUDAMED did not publish a description for this code.
• CW116

  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.
• CW999

  Contains sodium azide.
• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Spain; available across 13 countries total.

Trade name

Quantia PROTEINS Standard

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00380740157364

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

8436003070276XK

Reference / catalog number

6K45-03

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

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

Quantia PROTEINS Standard

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0102152203SPECIFIC PROTEIN STANDARDS AND CALIBRATORS

• IVDR Class B medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.