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Business Details
50+ Years
experience
Your Trusted Partner for Medical Diagnostic Solutions
EKF Diagnostics has been a trusted leader in medical diagnostics since 1960, dedicated to advancing healthcare through innovative diagnostic solutions. Our FDA-regulated manufacturing facility in Boerne, Texas produces high-quality clinical chemistry reagents, hemoglobin analyzers, and specialized diagnostic equipment trusted by medical facilities nationwide. We maintain rigorous quality standards through ISO 13485 and ISO 9001 certifications, ensuring our products meet the highest industry benchmarks. Our portfolio includes the Stanbio Chemistry brand of diabetes care reagents, the rapid-testing DiaSpect Tm hemoglobin analyzer, and the Creamatocrit Plus breast milk analyzer. With over six decades of experience, we combine deep industry expertise with cutting-edge technology to deliver reliable diagnostic solutions.

Our commitment to excellence extends to our customer support, technical assistance, and comprehensive quality control programs. We serve diverse healthcare settings including clinical laboratories, maternal health clinics, and point-of-care facilities across the United States. Our team of professionals takes pride in manufacturing medical devices that directly contribute to improved patient outcomes. Through continuous innovation and adherence to cGMP regulations, we maintain our position as a respected partner in diagnostic healthcare. Our long-standing reputation reflects our unwavering dedication to quality, accuracy, and customer satisfaction.
Services
Hemoglobin Analyzers Diabetes Reagents Lab Analyzers Rapid Tests Maternal Health Products
Details
  • Year established: 1960
Highlights and features
  • ISO 13485 and ISO 9001 certified quality management systems
  • 60+ years of specialized experience in diagnostic manufacturing
  • FDA-regulated facility with cGMP compliance
  • Diverse product portfolio for multiple healthcare settings
  • Comprehensive technical support and quality control programs
Associations and certifications
  • ISO 13485
  • ISO 9001
  • MDSAP
Services
Hemoglobin Analyzers
Our hemoglobin analyzers deliver lab-accurate results in seconds using advanced diagnostic technology. These portable devices provide critical blood analysis for clinical and point-of-care settings. Backed by ISO certifications, our analyzers ensure precise measurements for patient diagnostics and treatment monitoring.
Diabetes Reagents
Specialty reagents for diabetes care enable accurate beta-hydroxybutyrate testing on open channel systems. These liquid-stable reagents support comprehensive diabetes management in major medical facilities. Our FDA-regulated manufacturing ensures consistent quality for reliable clinical chemistry analysis.
Lab Analyzers
Benchtop laboratory analyzers offer comprehensive diagnostic capabilities for diverse clinical applications. Our equipment portfolio includes urine analyzers and breast milk composition testers. All analyzers meet strict regulatory standards for laboratory accuracy and diagnostic reliability.
Rapid Tests
Point-of-care rapid tests deliver accurate results for infectious diseases within ten minutes. These easy-to-use tests maintain high sensitivity for immediate clinical decision-making. Our rapid test portfolio includes Strep-A and occult blood detection solutions.
Maternal Health Products
Specialized diagnostic tools support maternal and neonatal health through pregnancy testing and anemia screening. Our QuPID and True 20 pregnancy tests provide accurate hCG detection. The Creamatocrit Plus system measures breast milk composition for nutritional assessment.
Questions
What types of diagnostic products does EKF offer?
We provide hemoglobin analyzers, diabetes reagents, maternal health diagnostics, rapid tests, and laboratory analyzers for clinical settings.
Are your products FDA approved?
Our Boerne, Texas facility operates under FDA regulations with current Good Manufacturing Practices (cGMP) compliance.
Do you offer technical support for your equipment?
Yes, we provide comprehensive technical support and account management for all diagnostic products.
What quality certifications do you hold?
We maintain ISO 13485, ISO 9001, and MDSAP certifications for quality management systems.
How can I request product information?
Contact us through our website form or call our toll-free number 1-800-531-5535 for product details.
Where are your products manufactured?
All products are manufactured at our FDA-regulated facility in Boerne, Texas since 1960.