Medical Devices
The FDA classifies medical devices based on their risks. The categories-Class I, Class II, and Class III- all express varying degrees of risks. At Accugen Laboratories, we offer a variety of tests to accommodate the intensity of risks associated with each category. The FDA requires testing for all products before passing them and Accugen Laboratories, Inc. assures that clients achieve the needed microbiological sterility of medical devices. We also conduct research and development studies to further improve medical devices.
Specific test performed on medical devices at Accugen Labs include:
- MIC/MIL test
- ASTM D1585
- Zone of Inhibition
- Time Kill Test
- Disinfectant tests
- Water testing
- Sterility testing
- Microbial Identification
- USP 71
- USP 61
- USP 62
- USP 85: Bioburden Testing
- Stability Testing
Accugen Labs performs testing on a variety of medical devices including:
- Lubricating Jelly
- Ultrasound Jelly
- Surgical Lubricant
- Contact Lenses
- Clotting Gel
- Dental floss
- Elastic bandages
- Examination Gloves