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Testing Services - Geneva Labs

Laboratory ServicesGeneva, IN • Since 1976

About

Geneva Laboratories, Inc. is a private medical device testing lab based in Elkhorn, Wisconsin (founded 1976). They provide cGMP/GLP-compliant services across toxicology/biocompatibility, microbiology, and chemistry for medical devices, pharmaceuticals, and personal care products. Key credentials include ISO 9001 and ISO/IEC 17025 certification, FDA establishment number 2182801, and DEA registration. With 14 employees, they offer personalized quality service and aim for timely, expert testing of materials, components, or products. Revenue is approximately $35.3 million. Services likely align with USP standards (e.g., USP 51, 61/62, 71) and ISO testing like ISO 11737-2 and ISO 11137-2, plus related stability and real-time/accelerated aging studies. Headquarters and four U.S. offices are in Elkhorn, WI. Contact: custservice@genevalabs.com; 262-723-5669.

Clinic Type

Laboratory Services

Address

1001 Proctor Drive, P.O. Box 140, Elkhorn, Wisconsin 53121, US

Phone

7159344000

Email

custservice@genevalabs.com

Opening Hours

Not published — contact the clinic to confirm hours.

Services Offered

  • Testing services
  • Biocompatibility testing
  • Chemical analysis
  • Pharmaceutical testing
  • Food additive testing
  • Reagent chemical testing
  • Compendial testing
  • Storage condition testing (extreme low temp, refrigeration, elevated humidity)
  • ICH/FDA and ASTM (Q10) guidance implementation

Insurance & Payment

Languages Spoken

FAQs

What is biocompatibility testing?

Biocompatibility is the process of evaluating materials used in the manufacture of medical devices and includes a number of tests to ensure safety.

What does Geneva Laboratories’ chemistry testing cover?

Quality compendial and non-compendial chemical analysis of raw materials and final products, including pharmaceuticals, food additives, and reagents.

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Photos

Information sourced from the clinic's website as of .

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