Terms of Use & Regulatory Compliance

Effective Date: October 1, 2026
Last Updated: October 1, 2026

Please review these Terms of Use and Regulatory Compliance Statements carefully prior to utilizing this website (renduanbiomed.com) or purchasing critical biological reagents from Renduan Biomedical Technology Co., Ltd. (“Renduan Biomed”). By accessing our website, submitting sample requests, or issuing purchase orders, you acknowledge and agree to comply with the terms set forth below.

1. Regulatory Status & RUO Compliance Notice

  • Research & Manufacturing Use Only: Unless explicitly stated otherwise in a formal, bilateral OEM manufacturing agreement, all monoclonal antibodies, matched antibody pairs, recombinant protein antigens, and calibrators supplied by Renduan Biomed are intended strictly for Research Use Only (RUO) or as raw materials/components for further manufacturing of In Vitro Diagnostic (IVD) test kits.
  • Prohibition of Human/Clinical Use: Products provided by Renduan Biomed are NOT approved for, and must NOT be used for:
    • Direct human therapeutic administration;
    • In vivo diagnostic applications in humans or animals;
    • Food, drug, agricultural, or cosmetic applications.
  • Customer Responsibility: The recipient/purchaser assumes sole responsibility for validating our raw materials within their proprietary assay platforms, securing all necessary regulatory registrations (e.g., CE-IVD, NMPA, FDA 510(k)/PMA), and adhering to local biosafety protocols.

2. Quality Standards & Limited Warranty

  • Certificate of Analysis (CoA) Conformity: Renduan Biomed warrants that at the time of dispatch, each delivered lot conforms strictly to the biochemical specifications stated in the official batch Certificate of Analysis (CoA) and Technical Data Sheet (TDS).
  • Storage & Handling Prerequisites: This warranty is conditioned upon the customer strictly adhering to the storage instructions specified on the product documentation (e.g., maintaining liquid antibodies at 2°C–8°C for short term or -20°C/-80°C for long term; preventing repeated freeze-thaw cycles; reconstituting lyophilized proteins with sterile buffers).
  • Warranty Claims: Any claim alleging that a delivered product fails to meet the documented CoA specifications must be submitted in writing to Renduan Biomed within thirty (30) calendar days of receipt, accompanied by comprehensive analytical raw data (e.g., SDS-PAGE, standard curves, or instrument sensorgrams). If a defect is confirmed by our Quality Assurance department, Renduan Biomed’s sole liability shall be limited to free product replacement or a full credit of the purchase price.

3. Commercial Inquiries, Pricing & Orders

  • Quotations: Quotations and pricing indicated on formal Proforma Invoices (PI) are valid for the period specified therein (typically 30 days). Official contract execution occurs upon formal written confirmation of a Purchase Order (PO).
  • Payment Terms: Standard international transactions are settled via wire transfer (T/T) against commercial invoices, unless alternative credit terms have been formally executed under an OEM supply agreement.
  • Cold-Chain Logistics: All biological reagents are shipped under qualified cold-chain packaging (e.g., insulated containers with blue ice or dry ice) via international priority couriers (FedEx/DHL). Standard Incoterms applied are DAP (Delivered at Place) or CPT (Carriage Paid To), unless mutually agreed otherwise.

4. Intellectual Property & Custom Synthesis (NDA Protection)

  • Proprietary IP: All trademarks, product names, molecular clone designations (e.g., RDM and RDP series), technical specifications, assay sensorgrams, and website content remain the exclusive intellectual property of Renduan Biomed.
  • Confidentiality & Custom Projects: For custom antibody generation, hybridoma development, or specific conjugation services (e.g., Acridinium ester, biotinylation), Renduan Biomed operates under strict bilateral Non-Disclosure Agreements (NDA). All customer-supplied target sequences, clinical matrix specifications, and proprietary assay formulations are held in absolute commercial confidence.

5. Limitation of Liability

In no event shall Renduan Biomed, its directors, officers, or research personnel be liable for any indirect, incidental, consequential, or punitive damages (including loss of profits, downtime, or clinical trial interruptions) arising out of the handling, storage, use, or inability to use our products, even if advised of the possibility of such damages.

6. Governing Law & Jurisdiction

These terms and any commercial transactions executed hereunder shall be governed by and construed in accordance with the laws of the People’s Republic of China, without regard to conflict of law principles. Any dispute arising out of or related to these terms shall be submitted to the competent courts having jurisdiction over Wujiang District, Suzhou, Jiangsu Province, China.

7. Regulatory & Technical Inquiries

For questions regarding product regulatory dossiers, quality system documentation, or industrial supply agreements, please reach out to: