Kee Diagnostics Logo
Background Laboratory Banner
Kee Diagnostics Pvt. Ltd

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.

Corporate Profile

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.

Manufacturing, Marketing, Export & Research

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.

GeM-Approved & Make-in-India Platform
Leadership Vision

Directors' Speech

Foundational principles, strategic commitments, and dedicated vision from the executive leadership of Kee Diagnostics.

Mr. Anil Motihar - Director, Kee Diagnostics
Leadership Message

Anil Motihar

Director, Kee Diagnostics Pvt. Ltd.

At Kee Pharma, we believe that the future of healthcare depends on innovation, quality, and the ability to provide reliable solutions that make a meaningful difference in people's lives. With this vision, we are proud to support the growth of Kee Diagnostics, our subsidiary dedicated to advancing diagnostic healthcare solutions.

The establishment of Kee Diagnostics reflects our commitment to expanding our contribution to the healthcare sector through reliable in-vitro diagnostic (IVD) solutions, scientific advancement, and a strong focus on quality. We understand that accurate and dependable diagnostics play a vital role in clinical decision-making and patient care.

At Kee Diagnostics, our objective is to build on the values of integrity, technical excellence, and continuous improvement while developing solutions that address the evolving needs of laboratories and healthcare professionals. We are committed to fostering a culture of scientific innovation, regulatory compliance, and customer confidence.

As we move forward, we aim to strengthen our capabilities, embrace emerging technologies, and build lasting partnerships with healthcare professionals, diagnostic laboratories, and industry stakeholders. We believe that our collective efforts will contribute to a more dependable and progressive diagnostic healthcare ecosystem.

I would like to thank our employees, partners, customers, and stakeholders for their continued trust and support. Together, we look forward to creating new opportunities and contributing to the advancement of diagnostic healthcare.

Anil Motihar • Director, Kee Diagnostics
Mr. Samir Biswas - Managing Director, Kee Diagnostics
35+ Years IVD Industry Experience

Samir Biswas

Managing Director, Kee Diagnostics Pvt. Ltd.

At Kee Diagnostics, our vision is to contribute to better healthcare through reliable, accurate, and high-quality diagnostic solutions. We believe that accurate diagnosis is the foundation of effective patient care, and we are committed to supporting healthcare professionals for easy handling of our reagent kits through dedicated automation program sheet and other technical details for entire range of parameters.

With extensive experience of 35 years in the in-vitro diagnostics industry, we continue to focus on research and development, technological advancement, product quality, and continuous improvement. Our expertise spans clinical chemistry, serology, specialty chemistry, and customized OEM solutions, enabling us to address the evolving needs of the diagnostic industry.

As an ISO 13485:2016 and ISO 9001:2015 certified organization, we are dedicated to maintaining stringent quality standards throughout our operations. We emphasize innovation, consistency, and customer satisfaction while continuously strengthening our capabilities in product development and manufacturing.

At Kee Diagnostics, we believe that our greatest strength lies in our people, our commitment to excellence, on time delivery and the trust of our customers and OEM partners. We strive to build long-term relationships through integrity, dependable products, and responsive service.

We do Bulk OEM supplies of Reagents, Prefilled bottles Finished kit format to our partners for establishing their brand image due to high quality reagents and technical support.

As we move forward, our focus remains on expanding our capabilities, embracing new technologies, and delivering diagnostic solutions that create lasting value for our valued business partners to excel and contribute to Indian & Global healthcare.

“Excellence is our commitment, quality is our foundation, and better healthcare is our purpose. We act today to create lasting value for tomorrow.”
Samir Biswas • Managing Director, Kee Diagnostics
Delhi Facility Tour

Inside Our Manufacturing & QC Infrastructure

Liquid Chemistry Manufacturing Area
Area 5: Liquid Chemistry

Formulation & Synthesis Suites

Dedicated controlled production suites for enzymatic buffer formulation and thermal stabilizer synthesis.

Automated Precision Bottling
Automated Filling

Peristaltic Dosing & Bottling

Precision high-speed peristaltic filling lines ensuring exact dosing and zero cross-contamination.

Quality Assurance Testing Laboratory
QA / QC Testing Desk

Analytical Release & Documentation

Multi-tier batch validation, spectrophotometric calibration, and comprehensive Certificate of Analysis release.

Company Milestone Evolution

HISTORY

Two Decades of Diagnostic Innovation & Growth

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.

Global Presence
Present

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.”

Driving Vision & Ethics

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.”

Bio-Technology & 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.”

Patient Healthcare & Quality of Life
Recognized R&D Unit

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.”

DSIR Recognized • Ministry of Science & Technology
Quality Assurance Commitment

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.”

Design, Implement, Monitor & Inspect
Verified Customer Feedback & Evaluation

Official Client

Testimonials & Endorsements

Real clinical evaluations from accredited pathology laboratories validating the accuracy, stability, and international EQAS ranking of Kee Diagnostics biochemistry reagents.

K
Kee DiagnosticsClinical Chemistry Division
NABL Lab Endorsement
Bio-Rad EQAS Validated

Mrityunjoy Debnath

Official Client Recommendation

Director, Organ Diagnostics & Scan Pvt. Ltd.

West Bengal & Bihar • Eastern India (NABL Accredited Network)

5.0 / 5.0 Clinical Rating

“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.”

5+ Years Routine UseBio-Rad EQAS Top RankingNABL Assessed LJ ControlsMindray BS 240 & BS Pro Compatible

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.

Download PDF File
Official Regulatory & Quality Accreditations

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 Certification2026 – 2029

CE Mark Certificate (IVDR 2017/746)

Issued by: European Union Conformity Body

Open PDF in New Tab

Official CE Mark Certification for In-Vitro Diagnostic Reagents & Diagnostic Devices.

ISO Quality2026 – 2029

ISO 9001:2015 Quality Management System

Issued by: Accredited ISO Certification Board

Open PDF in New Tab

Certified Quality Management System covering R&D, manufacturing, liquid stable reagent formulation, and customer support.

Medical Device ISO2025 – 2028

ISO 13485:2016 Medical Devices QMS

Issued by: Medical Device Quality Body

Open PDF in New Tab

Comprehensive Medical Device Quality Management System Certification for IVD Reagents and Equipment.

ADMI MembershipFY 2026–27

ADMI Membership Certificate

Issued by: Association of Diagnostics Manufacturers of India (ADMI)

Open PDF in New Tab

Official Certificate of Membership awarded to Kee Diagnostics Pvt. Ltd. as a registered manufacturer member of ADMI.

MSME Accreditation05-07-2025 (Registered)

Udyam Registration Certificate (Govt. of India)

Issued by: Ministry of MSME, Govt. of India

Open PDF in New Tab

Official Government of India Udyam MSME Registration Certificate for Kee Diagnostics Pvt. Ltd.

Govt. RegistrationActive Registration

GST Registration Certificate

Issued by: Goods and Services Tax Network, Govt. of India

Open PDF in New Tab

Official Goods and Services Tax (GST) Registration Certificate issued to Kee Diagnostics Pvt. Ltd.

Institutional & OEM Partnership

Upgrade Your Reagent Supply & Diagnostic Accuracy

Connect with our technical team for institutional pricing, bulk IVD supply, and private labeling.