Certified Method
Method Name: BAX® System PCR Assay Salmonella spp. 2
Purpose: Validated for the detection of Salmonella spp.
Manufacturer Information
Company: HYGIENA LLC
Address: 941 Avenida Acaso, Camarillo, CA 93012, United States
Manufactured By: HYGIENA LLC, 930 Flynn Road, Camarillo, CA 93012 USA
Validation Details
This decision attests that the alternative analysis method has been assessed by AFNOR Certification and found to conform to the standards cited and complementary requirements.
Technical Sheets Reference:
KIT2011 (D14368501) – INS2016 Rev 06
Validation Protocol:
NF EN ISO 16140-2 (September 2016): Microbiology of the food chain. Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method.
Reference Method(s):
NF EN ISO 6579-1 (April 2017) and its amendment A1 (March 2020): Microbiology of the food chain - Horizontal method for the detection, enumeration and serotyping of Salmonella - Part 1: detection of Salmonella spp.
Scope of Application:
All human food products (by performing validation assays on a broad range of foods), feed products and industrial production environmental samples.
Restrictions:
None.
Warnings:
None.
Other Information:
The scope includes the use of instruments BAX® System Q7 with BAX® software version 5.0, and BAX® System X5 version 1.0.
Certification Authority
[NF Validation Logo] [AFNOR Certification Logo]
The method is authorized to affix the NF VALIDATION mark in accordance with NF VALIDATION general rules and certification rules NF102 - Validation of alternative analysis methods (Application to the food industry).
This certificate supersedes all previous certificates. It is subject to regular controls by AFNOR Certification.
[Cofrac Accreditation Logo]
Further Information and Resources
For queries concerning the performances of the certified alternative method, please contact AFNOR Certification.
Download the validation study summarized report: http://nf-validation.afnor.org/en
More information on the certification website: http://nf-validation.org/en
Signatory
[Signature]
Managing Director: Julien NIZRI
