IVD-grade Probes & Primers | China Company

Overview

The transition from research to approved in vitro diagnostics requires reagents of exceptional quality and traceability. Tsingke's IVD-grade oligonucleotides are produced under a certified quality management system, providing the consistency, documentation, and performance needed for your regulated diagnostic development.

Challenges

Meeting stringent regulatory requirements (FDA, CE IVDR)

Ensuring lot-to-lot consistency for long-term assays

Managing supply chain risk for critical components

Navigating complex documentation and compliance needs

Tsingke Solutions

Dual-Quencher Probes

BHQ and MGB probes offering superior fluorescence quenching and specificity.

Modified Primers

Chemically modified bases (e.g., LNA, ZNA) for enhanced binding and allele discrimination.

Full Quality Documentation

Provided Certificate of Analysis (COA) and compliance with ISO 13485.

Custom Modifications

A wide range of dyes, quenchers, and backbone modifications to meet specific assay needs.

Why Tsingke?

Superior Probe Technology

Dual-quencher probes (BHQ & MGB) deliver exceptional fluorescence quenching and unmatched target specificity, reducing background noise and enhancing signal clarity.

Advanced Primer Design

Chemically modified primers (LNA/ZNA) significantly improve binding affinity and allele discrimination power, enabling reliable detection of low-frequency variants.

Regulatory Compliance Assurance

Full quality documentation including ISO 13485-compliant Certificate of Analysis (CoA) ensures seamless integration into your diagnostic pipeline.

Tailored Modification Options

Comprehensive customization of dyes, quenchers, and backbone modifications to optimize assay performance for your specific application needs.

Build your diagnostic assays on a foundation of quality and compliance.

Choose Tsingke as your trusted IVD-grade oligo partner.