Compliance Terms
Standard terms and conditions for IVD diagnostic reagent use and procurement.
Terms of Product Use & Laboratory Compliance
By accessing our digital services, downloading technical product inserts, or procuring In-Vitro Diagnostic (IVD) reagents and laboratory instrumentation from Kee Diagnostics Pvt. Ltd., you agree to the regulatory and commercial compliance terms outlined below.
1. In-Vitro Diagnostic (IVD) Usage
All clinical chemistry reagents, serological slide agglutination kits, quantitative turbidimetric assays, and hematology solutions manufactured by Kee Diagnostics are intended solely for professional in-vitro diagnostic laboratory use by certified laboratory personnel and pathology institutions. They are not intended for internal human or animal administration.
2. Adherence to Instructions for Use (IFU)
Analytical linearity, assay recovery rates, and shelf-life guarantees are conditional upon strict adherence to the handling, storage (2°C–8°C unless specified otherwise), calibration protocols, and photometer/analyzer parameters set forth in official Kee Diagnostics package inserts (IFUs).
3. Quality Assurance & Lot Traceability
Every production lot undergoes documented quality control evaluation against international standard reference materials prior to release. Lot-specific certificates of analysis (COA) and target value assignment sheets are provided for multi-calibrators and controls upon request.
4. Institutional Procurement & GeM Compliance
Government and hospital procurement contracts, including those fulfilled under the Government e-Marketplace (GeM) and Make-in-India guidelines, are subject to verified purchase order terms and mutual institutional agreements.