Microbiology & Pathology in Texas

Steritec Services LLC is a contract sterilization and biological testing provider specializing in medical device processing. The company operates a 54,000 square foot facility in Athens, Texas, equipped with ethylene oxide (EO) and steam sterilization chambers, along with comprehensive chemical and biological testing laboratories. Core services include 100% ethylene oxide sterilization, steam sterilization, sterility testing, LAL endotoxin analysis, EO residuals testing, and bioburden assessment. The company serves medical device manufacturers requiring validated sterilization processes and regulatory-compliant testing support, including ISO 11135 process validation, biological indicator testing, and process validation documentation. Steritec also provides professional consulting guidance for regulatory compliance and sterilization program development.

Gentech Diagnostics is a CLIA/COLA-certified reference laboratory providing comprehensive diagnostic testing services exclusively to healthcare providers. The company specializes in molecular testing and toxicology analysis with rapid turnaround times (24-48 hours for most results). Operating as a B2B laboratory service provider, Gentech Diagnostics does not perform direct-to-patient testing and works exclusively with ordering physicians and healthcare facilities. The laboratory is licensed to serve healthcare providers across Texas, California, and Arizona, with board-certified specialists conducting expert analysis and interpretation of test results. The company is enrolled as a Medicare and Medicaid provider and maintains HIPAA compliance, CAP accreditation, and Privacy Shield certification. Gentech Diagnostics positions itself as a trusted reference laboratory setting standards in medical diagnostics through advanced technology and professional analysis capabilities.

INCELL Corporation LLC is a GMP (Good Manufacturing Practice) contract manufacturer and services provider headquartered in San Antonio, Texas. The company specializes in research, development, manufacturing, and cryostorage of cells, tissues, and support products for regenerative medicine applications. INCELL operates as both a manufacturer of proprietary cell culture media, collection and transport solutions, and cryopreservation media, and as a service provider offering cell and tissue culture, banking, and testing services. The company serves research institutions, clinical laboratories, and therapeutic development partners. INCELL manufactures branded product lines including M3™ and M4™ culture media families, EZ-CPZ™ cryopreservation media, collection and transport solutions (ZTM series), processing buffers (ZSol-F™), and RBC lysing buffers (ZAPR™). The company also develops and supplies proprietary cell lines, including monoclonal antibody-producing hybridoma lines and specialized cell lines (NCM460D, NCM356D). In addition to manufacturing, INCELL provides contract manufacturing services for regenerative medicine therapies, microbiology diagnostics and therapeutics, personalized medicine approaches (including patient tumor culture and cryostorage for cancer patients), and clinical trial support through its subsidiary 4RMED LLC. The company's regulatory expertise and manufacturing capabilities align with FDA oversight of human cells and tissues products. INCELL holds GMP certification and operates under standards applicable to cell and tissue manufacturing. The company serves pharmaceutical, biotechnology, academic research, and hospital laboratory markets, with notable focus on regenerative medicine and cell therapy development, including involvement in ALS cell therapy clinical applications.

C.G. Laboratories, Inc. is a multi-service medical device contract manufacturer and testing laboratory founded in 1983 and headquartered in Granbury, Texas. The company specializes in medical device decontamination, contract packaging, laboratory testing, sterilization validation, and environmental monitoring. With over 40 years of operational experience and 19,000 square feet across two facilities, C.G. Labs serves the medical device, tissue, and dental industries. The company is FDA-registered and ISO 13485:2016 and MDSAP accredited. Core competencies include microbiological analysis, regulatory testing, reusable medical device validation, water testing, air microbial monitoring, and IFU development. C.G. Labs offers customizable decontamination and sterilization services with turnaround times exceeding 72-hour performance objectives, end-to-end contract packaging (sterile and non-sterile), and comprehensive validation support including process validation and equipment qualification. The laboratory team collectively has over 90 years of medical device industry experience.