High-Tech In-Vitro
Diagnostics Enterprise
Kee Diagnostics Pvt. Ltd. is a leading high-tech In-Vitro Diagnostics (IVD) company engaged in the Manufacturing, Marketing, Export and Research of advanced Diagnostic Reagents and Devices. With a strong focus on innovation and quality, we are dedicated to delivering reliable diagnostic solutions that support modern healthcare.
ABOUT US
In-Vitro Diagnostics Enterprise
Kee Diagnostics Pvt. Ltd. is a leading high-tech In-Vitro Diagnostics (IVD) company engaged in the Manufacturing, Marketing, Export and Research of advanced Diagnostic Reagents and Devices. With a strong focus on innovation and quality, we are dedicated to delivering reliable diagnostic solutions that support modern healthcare.
Recognized as one of India's fastest-growing MSME companies, Kee Diagnostics operates a state-of-the-art manufacturing facility in the heart of Delhi. As an ISO 13485:2016 and ISO 9001:2015 certified organization, we are committed to manufacturing high-quality diagnostic products that consistently meet international quality and industry standards.
Comprehensive Range & Professional Team
Our expertise spans Research and Development, manufacturing and supply of a comprehensive range of In-Vitro Diagnostic (IVD) products, including Diagnostic Kits in Liquid-Stable and Dry Powder, Controls & Calibrators, System Packs for various Fully Automated Biochemistry Analyzers, Serology Reagents based on Latex and Turbilatex technology, and Special Chemistry products. We also specialize in OEM manufacturing offering Bulk Reagents, Prefilled Vials, Finished Reagent Kits, and dedicated System Packs compatible with a wide range of Fully Automated Analyzers available in the Indian market. As a trusted GeM-approved Institutional Supplier and a regulatory-ready manufacturing platform, we are positioned to support large scale healthcare initiatives under the Make-in-India vision.
Kee Diagnostics Pvt. Ltd. is professionally managed by a team of highly qualified and experienced professionals across Manufacturing, Research & Development, Sales & Marketing, Exports and Technical Services. Driven by innovation, uncompromising quality and customer satisfaction, we strive to provide dependable healthcare solutions that earn the trust of healthcare professionals and partners across India and international markets.
Inside Our Manufacturing & QC Infrastructure
Area 5: Liquid ChemistryFormulation & Synthesis Suites
Dedicated controlled production suites for enzymatic buffer formulation and thermal stabilizer synthesis.
Automated FillingPeristaltic Dosing & Bottling
Precision high-speed peristaltic filling lines ensuring exact dosing and zero cross-contamination.
QA / QC Testing DeskAnalytical Release & Documentation
Multi-tier batch validation, spectrophotometric calibration, and comprehensive Certificate of Analysis release.
HISTORY
The company was incorporated, Kee Biogenetics Pvt. Ltd, on 2004. In 2009, the name was changed to Kee GAD Biogen Pvt Ltd engaged in manufacturing and consequently, in 2015, it was rebranded as Kee Diagnostics Pvt. Ltd because of its increased scope of setting up complete Diagnostic company under a single roof & leadership. At present Kee Diagnostics Pvt. Ltd engaged with R&D, Manufacturing, Import & Export, Sales & Marketing, Marketing Research for Reagents as well various Devices in Laboratory management.
Present Operations
“At present Kee Diagnostics Pvt. Ltd engaged with R&D, Manufacturing, Import & Export, Sales & Marketing, Marketing Research for Reagents as well various Devices in Laboratory management.”
VALUES & MISSION
MISSION
“Our mission is to be knowledge based bio-technology company and contribute to the growth of the Indian diagnostic sector and public healthcare.”
VALUES
“Our values are based on our vision of improving healthcare and driven by ethics with scientific temper, innovation with compassion, and a commitment to patient healthcare and quality of life.”
R & D
“Our R&D unit is recognized by the Department of Scientific and Industrial Research of the Ministry of Science and Technology, Govt. of India. We recognize that R&D is the propeller for innovation and excellence and are committed to constantly seek enhanced improvements and performance of our products.”
QUALITY POLICY
“Our commitment to quality assurance is reflected in our dedicated team of professionals who design, implement and monitor every facet of the production process including inspections and testing before launch.”
Official Client
Testimonials & Endorsements
Real clinical evaluations from accredited pathology laboratories validating the accuracy, stability, and international EQAS ranking of Kee Diagnostics biochemistry reagents.
Mrityunjoy Debnath
Official Client RecommendationDirector, Organ Diagnostics & Scan Pvt. Ltd.
West Bengal & Bihar • Eastern India (NABL Accredited Network)
“Organ Diagnostics & Scan Pvt. Ltd. is a renowned NABL accredited Laboratory with multiple diagnostic branches across West Bengal & Bihar of Eastern India. We are using Kee Diagnostics Pvt. Ltd. range of products in our laboratories over the past 5 years and having very good EQAS ranking reports from international brand Bio-Rad.”
“NABL Authorities are doing regular assessments & certifies on quality of reports, showing their great satisfaction after observing Levey-Jennings (LJ) charts of our operating systems for Bio-Rad controls on both levels. Reagents exhibit zero drift and remarkable onboard stability.”
“Once again, we recommend using clinical chemistry products manufactured by Kee Diagnostics Pvt. Ltd. due to their high analytical accuracy, lot-to-lot consistency, and very stable reagents on fully automated instruments like Mindray BS 240 & BS Pro models.”
Documented Highlights from the Client Evaluation
Extracted directly from the official appreciation letter filed by Organ Diagnostics & Scan Pvt. Ltd.
5+ Years Active Routine Use
Proven daily high-volume usage across multiple diagnostic branches.
Bio-Rad EQAS International Top Rank
Gold-standard external quality assurance ranking with Bio-Rad controls.
NABL Assessed LJ Control Charts
NABL assessors routinely validate stability on both control levels.
Mindray BS 240 & Pro Compatible
Exceptional reagent linearity & stability on fully automated instruments.
Official Document Reference: Customer-Feedback.pdf
Signed & stamped recommendation on original corporate letterhead.
Certificates & Accreditations
Interactive 1st page visual PDF preview and downloadable copies for CE Mark, ISO 9001:2015, ISO 13485:2016, MSME Udyam, and CDSCO Form MD-5.
CE Mark Certificate (IVDR 2017/746)
Issued by: European Union Conformity Body
Official CE Mark Certification for In-Vitro Diagnostic Reagents & Diagnostic Devices.
ISO 9001:2015 Quality Management System
Issued by: Accredited ISO Certification Board
Certified Quality Management System covering R&D, manufacturing, liquid stable reagent formulation, and customer support.
ISO 13485:2016 Medical Devices QMS
Issued by: Medical Device Quality Body
Comprehensive Medical Device Quality Management System Certification for IVD Reagents and Equipment.
ADMI Membership Certificate
Issued by: Association of Diagnostics Manufacturers of India (ADMI)
Official Certificate of Membership awarded to Kee Diagnostics Pvt. Ltd. as a registered manufacturer member of ADMI.
Udyam Registration Certificate (Govt. of India)
Issued by: Ministry of MSME, Govt. of India
Official Government of India Udyam MSME Registration Certificate for Kee Diagnostics Pvt. Ltd.
GST Registration Certificate
Issued by: Goods and Services Tax Network, Govt. of India
Official Goods and Services Tax (GST) Registration Certificate issued to Kee Diagnostics Pvt. Ltd.
Upgrade Your Reagent Supply & Diagnostic Accuracy
Connect with our technical team for institutional pricing, bulk IVD supply, and private labeling.