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Precision Molecular Diagnostics for a Healthier World

Singuway Biotech Inc. is a leading manufacturer of RT PCR Test Kits, Real Time PCR Analyzers, and Nucleic Acid Extraction Systems. ISO13485 & CE certified. Trusted by laboratories and hospitals worldwide since 2017.

39+
RT PCR Kits
14+
PCR Analyzers
21+
Extractors
2017
Founded
RT PCR Test Kit

Who We Are

Singuway Biotech Inc. is a leading molecular diagnosis company established in Shenzhen in 2017. We are a comprehensive high-tech enterprise integrating scientific research, development, production, and sales.

Our mission is to provide reliable, accurate, and innovative molecular diagnostic solutions to laboratories, hospitals, and public health institutions around the world. With ISO13485 certification and CE-marked products, we ensure the highest standards of quality and safety.

ISO13485 & CE Certified Manufacturing
Global Distribution Network
Ultrafast RT PCR Detection in 30 Minutes
High Sensitivity Down to 50 Copies/ml
Mutation Detection Kit Sample Release Reagent PCR Analyzer Antigen Test Kit

Our Premium Products

High-performance molecular diagnostic solutions trusted by laboratories and healthcare providers worldwide.

Rapid IgM Self Test Kit

Rapid IgM Self Test Kit

Colloidal gold method antibody self-test kit for quick and reliable detection.

Technology: Colloidal Gold
Application: Antibody Detection
Certification: CE
IVD
Mutation Detection Kit

Alpha/Beta/Delta/Gamma Mutation qPCR Kit

One-step qPCR kit for lab use with oral swab samples to detect major coronavirus variants.

Target: SARS-CoV-2 Variants
Sample: Oral Swab
Standard: ISO13485
Mutation Detection
Sample Release Reagent

Sample Release Reagent Kit

Nucleic acid and microRNA extraction kit with 100 tubes, ISO13485 certified.

Capacity: 100 Tubes
Application: RNA/DNA Extraction
Certification: ISO13485
Extraction Kit
RT PCR Analyzer

32-Well RT PCR Analyzer

Mini qPCR machine with 4 channels, ideal for hospital and laboratory use.

Capacity: 32x0.2ml
Channels: 4
Weight: 6.5kg
Thermal Cycler
Rapid Antigen Test Kit

High Sensitivity Rapid Antigen Test Kit

Manual RT PCR rapid antigen self-test cassette with high sensitivity for point-of-care testing.

Method: Cassette Format
Use: Self-Testing
Speed: Results in Minutes
POCT
CMV Virus RT PCR Kit

CMV Virus RT PCR Test Kit

Real-time nucleic acid testing kit for Cytomegalovirus detection with ISO13485 certification.

Target: CMV Virus
Method: Real-Time PCR
Certification: ISO13485
Viral Detection
Flu A/B One Step PCR Kit

Flu A/B One Step Real Time PCR Kit

Highly sensitive detection kit for Influenza A and B viruses with 96 tests per kit.

Targets: Flu A, Flu B
Tests: 96
Sensitivity: High
Respiratory Panel
4x8 Well Dual Block Analyzer

4x8 Well Dual Block Real Time PCR Analyzer

Rapid test machine for 32x0.2ml samples with dual block design for increased throughput.

Capacity: 32 Samples
Blocks: Dual 4x8
Application: Laboratory Testing
High Throughput

Why Choose Singuway Biotech?

We combine cutting-edge technology, rigorous quality control, and global compliance to deliver reliable diagnostic solutions.

Global Certifications

ISO13485, CE, and IVD certified products meeting international quality standards.

Ultrafast Detection

Results in as little as 30 minutes with high sensitivity down to 50 copies/ml.

Comprehensive Range

Over 120 products including test kits, analyzers, extractors, and accessories.

Global Support

Distributed in 50+ countries with multilingual technical and sales support.

120+
Products
50+
Countries
2017
Founded
99.8%
Accuracy Rate

Frequently Asked Questions

Are your products CE certified?

Yes, many of our RT PCR test kits and analyzers are CE certified for in vitro diagnostic use. We comply with EU IVDR requirements for medical devices.

What is the detection time for your RT PCR kits?

Our ultrafast RT PCR test kits provide results within 30 minutes, making them ideal for rapid diagnosis in clinical and point-of-care settings.

Do you offer private labeling and OEM services?

Yes, we provide comprehensive OEM and ODM services including custom packaging, labeling, and product development based on client specifications.

What sample types are compatible with your test kits?

Our kits support various sample types including nasal swabs, oral swabs, saliva, serum, plasma, whole blood, and tissue fluids depending on the specific product.

What quality standards do you follow?

We operate under ISO13485 quality management system and all our manufacturing processes follow strict GMP guidelines to ensure product consistency and reliability.

Get in Touch

For product inquiries, quotations, or technical support, please visit our official website.

Visit Official Website to Contact

Singuway Biotech Inc. | Established 2017 | Shenzhen, China

Distributing high-quality molecular diagnostic solutions worldwide

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