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ISO 13485:2016 Certification represents the gold standard for medical device quality management systems globally, and Innocreate Bioscience is proud to announce that our manufacturing and design protocols have officially met this rigorous benchmark. Following a comprehensive assessment by SGS United Kingdom Ltd, our facility has been granted full certification.
This milestone covers our core capabilities in the design and manufacture of nucleic acid testing kits and reagents for infectious diseases. For our global partners, this achievement acts as an independent validation that Innocreate’s molecular solutions are built under the strictest international regulatory quality frameworks.
Elevating Quality from Lab to Farm
Since our founding in 2014 to commercialize breakthrough scientific discoveries, Innocreate Bioscience has been driven by data and clinical precision. We deliver advanced molecular protocols and precision disease management tools that form a critical baseline for biosecurity. Quality control is not simply a compliance measure for us; it is at the center of our operational philosophy.
Securing this formal ISO 13485:2016 Certification validates that our manufacturing and development lines match global medical-grade specifications. This standard is highly sought after because it demands total batch-to-batch consistency, complete material traceability, and strict risk management paradigms. By embedding these medical-grade frameworks into our everyday workflows, we guarantee that every rapid test and detection kit arriving at a facility delivers the elite accuracy required to protect livestock, manage pandemics, and stabilize supply chains.
Official Certificate Breakdown
- Standard Reached: ISO 13485:2016 / EN ISO 13485:2016
- Certified Scope: Design and manufacture of nucleic acid testing kits and reagents for infectious diseases
- Certification Body: SGS United Kingdom Ltd
- Registration Identification: Certificate TW26/00000347
- Term of Validity: May 8, 2026 – May 8, 202
Bridging Human Public Health and Sustainable Aquaculture
What makes Innocreate Bioscience unique is our ability to apply elite molecular diagnostics across multiple domains. In the sphere of human health, our expertise has powered successful public screening initiatives. Our technologies have anchored critical infrastructure like the multiplex SARS-CoV-2 QD Kits utilized by Seeing Bioscience and top-tier government agencies—including the Taiwan CDC—for early-warning wastewater epidemiology networks.
Concurrently, we have translated these exact high-throughput engineering standards over to aquaculture biosecurity. Marine pathogens like White Spot Syndrome Virus (WSSV) threaten food security and can cause total crop mortality within days if left unchecked. Our flagship field diagnostics provide an easy-to-use, “pondside” answer that performs with the sensitivity of a traditional laboratory setup. Backed by our newly verified ISO 13485:2016 Certification, shrimp and fish farmers can use our tools with absolute certainty, bypassing the standard logistical wait times of centralized testing facilities to isolate outbreaks instantly.
Your Partner in Biotech Excellence
This operational milestone marks the next phase of our global market expansion. It follows a highly decorated period for our team, including our selection as a Top 3 Global Finalist at the 2025 Responsible Seafood Innovation Awards in Cartagena, Colombia, and our recent successful technology showcase at VietShrimp 2026.
International compliance via an accredited ISO 13485:2016 Certification cements our standing as a premium OEM, ODM, and collaborative partner for academic institutions, teaching hospitals, international distributors, and large-scale commercial farming networks worldwide. Whether configuring custom assays for emerging regional variants or supplying mass-screening reagents to public health departments, Innocreate stands ready to deliver verified quality. We remain deeply committed to harnessing biotechnology to build a healthier, highly resilient, and sustainable future.
Get in Touch
Do you have technical inquiries regarding our certified molecular diagnostic pipelines, custom diagnostic reagent manufacturing, or strategic international distribution opportunities? Our scientific support team is available to assist you.
Email: info@innocreatebio.com
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About Innocreate Bioscience
Innocreate Bioscience Co., Ltd. is a leader in aquatic health technology, specializing in the development of rapid, reliable, and accessible diagnostic tools. Its flagship WSSV RP Rapid Test Kit is a finalist for the 2025 Responsible Seafood Innovation Award, reflecting the company’s ongoing impact on global food security.
