Diagnostic Reagents for
Accurate and Reproducible Results

Creating the future where rapid, precise,
and accessible diagnostics are the standard

ISO 13485:2016 and EN ISO 13485:2016 + AC:2018 + A11:2021 Quality Management System

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SignalChem Diagnostics is certified to
EN ISO 13485:2016 + AC:2018 + A11:2021 and ISO 13485:2016
This internationally recognized certification demonstrates our
commitment to maintaining a robust Quality Management System,
meeting applicable regulatory requirements, and continuously
improving our processes to deliver consistent and reliable products.



Our Focus

SignalChem Diagnostics, a subsidiary of SignalChem
Lifesciences Corporation, specializes in protein engineering
for molecular, immunological, and clinical chemistry tests,
and the development and manufacturing of rapid pathogen detection kits.

Recently Launched Products

NEWS AND MILESTONES

Company Highlights

Featured news from SignalChem Diagnostics

View All News ➞
ISO 13485 Certified
COMPANY NEWS July 20, 2026

SignalChem Diagnostics Granted ISO 13485 Certification

A quality management system supporting consistent product quality.

Read More
Research publications
RESEARCH July 16, 2026

Recent Publications Featuring Our CRISPR Products

Explore selected research using SignalChem Diagnostics CRISPR-associated proteins.

Read More
CRISPOT® detection device
PRODUCT NEWS July 8, 2026

CRISPOT® Detection Device Receives CE Mark

A milestone for our portable fluorescence-based detection platform.

Read More
Signalchemdx Logo in White

Diagnostic Reagents For
Acccurate And Reproducible Results

Creating the future where rapid, precise,
and accessible diagnostics are the standard

rapid, precise, and accessible

diagnostics are the standard

 

 

 

ISO 13485:2016 and EN ISO 13485:2016 + AC:2018 + A11:2021 Quality Management System

SignalChem Diagnostics is certified to
EN ISO 13485:2016 + AC:2018 + A11:2021 and ISO 13485:2016
This internationally recognized certification demonstrates our commitment to maintaining a robust Quality Management System, meeting applicable regulatory requirements, and continuously improving our processes to deliver consistent and reliable products.

ISO 13485 Certified

Our Focus

SignalChem Diagnostics, a subsidiary of SignalChem
Lifesciences Corporation, specializes in protein engineering
for molecular, immunological, and clinical chemistry tests,
and the development and manufacturing of rapid pathogen detection kits.

Recently Launched

Products

View 2026 Product Portfolio

NEWS AND MILESTONES

Company Highlights

Featured news from SignalChem Diagnostics

View All News ➞
ISO 13485 Certified
COMPANY NEWS July 20, 2026

SignalChem Diagnostics Granted ISO 13485 Certification

A quality management system supporting consistent product quality.

Read More
Research publications
RESEARCH July 16, 2026

Recent Publications Featuring Our CRISPR Products

Explore selected research using SignalChem Diagnostics CRISPR-associated proteins.

Read More
CRISPOT® detection device
PRODUCT NEWS July 8, 2026

CRISPOT® Detection Device Receives CE Mark

A milestone for our portable fluorescence-based detection platform.

Read More

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CRISPR-Cas Systems

Molecular Diagnostics Mixes

Isothermal Amplification

Affinity Proteins and Resins

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