DocuSign Envelope ID: 8A00777F-C4CC-4227-A159-9599FE2A4C2B

Science Park CREALYS

Rue Jean Sonet 4A
5032 - GEMBLOUX - BELGIUM
TEL : + 32(0)81.719.917
FAX : +32(0)81.719.919
e-mail : info@corisbio.com
http://www.corisbio.com

Notification of change

Notification date: 05 December 2022

Change control reference: 2022-007

The purpose of this notification is to inform you about a change which impacts the product(s)
purchased.

Impacted devices:
The changes concern the following products in the catalog:
Product code Product name
K-15R5 RESIST-3 O.K.N.
K-15R11 O.K.N.V.I. RESIST-5
K-15R13 RESIST ACINETO
K-15R14 RESIST CTX-M

Description and reason of the change:

- Change of the disposable collection tubes supplied in the products above to improve
biosafety when vortexing the preparation to be homogenized as recommended by the
instructions for use of kit RESIST: the new tube has a cap.
- Equivalence with the former capless tube has been demonstrated.
- IFU have been modified accordingly.

Please see the comparative pictures below :

Former tube (packaged in zip bag) New tube

Reference F-AML-08 Letter type notification (Template v1 – Edition 22/02/2022)

S:\00-Système Qualité_Enregistrements\10 Amélioration (AML)\03 Change Control\(change number)
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Enregistrement :
DocuSign Envelope ID: 8A00777F-C4CC-4227-A159-9599FE2A4C2B
Science Park CREALYS
Rue Jean Sonet 4A
5032 - GEMBLOUX - BELGIUM
TEL : + 32(0)81.719.917
FAX : +32(0)81.719.919
e-mail : info@corisbio.com
http://www.corisbio.com

Implementation date:
December 2022
Transmission of this Notice:
This notice needs to be passed to all those who need to be aware within your organization or to
any organization where the modified devices have been transferred.
Please transfer this notice to other organizations on which this action has an impact.
Contact reference:
If you would like more information about this change notification, please contact our sales or
client care department:

Sales department: sales@corisbio.com

Client care department client.care@corisbio.com
Coris BioConcept
Science Park CREALYS
Rue Jean Sonet 4A - 5032 - GEMBLOUX - BELGIUM
TEL : + 32(0)81.719.917 - FAX : +32(0)81.719.919

Signature (name, function and date):

Corentin Meurisse
QA & RA Assistant
05/12/2022

Reference F-AML-08 Letter type notification (Template v1 – Edition 22/02/2022)

S:\00-Système Qualité_Enregistrements\10 Amélioration (AML)\03 Change Control\(change number)
2/2
Enregistrement :