Organization name

Agilent Technologies, Inc.

SRN

US-MF-000009385

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW041

  EUDAMED did not publish a description for this code.

Primary placement in Denmark; available across 32 countries total.

Trade name

Dako Liquid Permanent Red

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.

05700571103784

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.

570057P3007P3010A029501P8

Reference / catalog number

K0640

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 A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

LIQUID PERMANENT RED CHROMOGEN, LIQUID PERMANENT RED SUBSTRATE BUFFER

Additional information URL

https://www.agilent.com/en/library/eifu.html

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.

• W01030708STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)

• IVDR Class A medical devices in EUDAMED

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