220-000

Organization name

Institut de Biotechnologies Jacques Boy

SRN

FR-MF-000004609

Manufacturer status

Active

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

• CW036

  EUDAMED did not publish a description for this code.
• CW018

  EUDAMED did not publish a description for this code.
• CW012

  EUDAMED did not publish a description for this code.

Primary placement in France; available across 2 countries total.

Trade name

not provided

UDI-DI code

03770008181670

Basic UDI-DI

3770008181220-000YY

Reference / catalog number

220-000

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 K-Matic is a device that automates the four steps of staining blood smears in the Kleihauer test. It is designed exclusively for use in combination with the reagents in the K-Matic Kit (ref. 901080133, IBJB and ref. 901080134, IBJB). The K-Matic system ensures protocol reproducibility by reducing inter-operator variability, secures the staining process and reagent usage, and facilitates the work of laboratory users.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0299IVD INSTRUMENTS - OTHER

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