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Certifications & Patents

We understand the importance of our products and services meeting your complex business needs. Our scientists and subject matter experts work behind the scenes to stay updated on the latest testing requirements and develop innovative solutions to help your business succeed. Our products are backed with proper certifications and patents to provide the necessary documentation for audits and site visits.

ISO Certifications

Hygiena LLC (ISO 9001:2015)

Hygiena Diagnostics GmbH DE (ISO 9001:2015)

Hygiena Diagnostics GmbH EN (ISO 9001:2015)

Qualicon CA (ISO 9001:2015)

Qualicon DE (ISO 9001:2015)

Helica CA (ISO 13485:2016)

BioChek UK (ISO 9001:2015)


Hygiena Diagnostics GmbH - Approval for veterinary diagnostics 

Hygiena Diagnostics GmbH - Manufacturing License for veterinary diagnostics


BAX® System Standard PCR Assay for E. coli O157:H7 MP

U.S. Patent No.: 8,232,057

BAX® System Real-Time PCR Assay for E. coli O157:H7

U.S. Patent Nos.: 8,846,349; 9,481,913; other patents pending

BAX® System Real-Time PCR Assay for Salmonella

U.S. Patent No.: 9,388,473

BAX® System Real-Time PCR Assay for STEC Screening

U.S. Patent No.: 8,802,371; 9,528,162

BAX® System Real-Time PCR Assay for L. monocytogenes

Patents Pending: U.S. Pat. Appl’n

BAX® System SalQuant®

U.S. Patent Application No: 16/549,059