Compliance & Quality Assurance
Our detection kits are manufactured under ISO 13485:2016 quality management systems, ensuring consistency, reliability, and traceability. We adhere to Good Manufacturing Practices (GMP) where applicable, guaranteeing that our reagents meet the highest industry benchmarks.
Intended Use & Limitations
Our products are for research use only (RUO) and should not be used in clinical diagnostics or human treatment.
They are optimized for cell therapy product characterization, safety testing, and process monitoring.
Users must follow proper laboratory protocols and biosafety guidelines when handling our reagents.
Regulatory Considerations
Our reagents support compliance with FDA (21 CFR Part 210/211), EMA (European Medicines Agency), and ICH (International Council for Harmonisation) guidelines for cell and gene therapy product testing.
While our kits are not FDA-approved for clinical use, they assist in meeting critical quality attributes (CQAs) required for regulatory submissions.
Safety & Handling
All reagents undergo rigorous quality control (QC) to ensure performance and reproducibility.
Proper storage conditions and handling procedures must be followed as specified in the product documentation.
Users should refer to Material Safety Data Sheets (MSDS) for hazard and disposal guidelines.
Customer Responsibility
Customers are responsible for:
Validating our reagents for their specific applications.
Ensuring compliance with local regulations for cell therapy product testing.
Using our products only for their intended research purposes.
For further details, please refer to our product manuals or contact our technical support team at bluekitbio@hillgene.com.
BlueKitBio – Advancing Cell Therapy Research with Precision & Compliance
Post time: 2025-05-26 14:25:27
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