Isle Media and Sterile Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 93
What Isle Media and Sterile Products, Inc. makes
Isle Media and Sterile Products, Inc. manufactures microbiological culture media and transport solutions, including agar plates, broths, and selective/differential media for bacterial and fungal identification. Products include Brain Heart Infusion Agar, Mannitol Salt Agar, Tryptic Soy Broth, and specialized media like Modified Thayer-Martin Agar for specific pathogen detection. Transport media like Amies Medium are also part of the portfolio, designed for sample preservation during clinical testing.
The company’s products are regulated under FDA’s Class I and Class II device classifications, with many authorised via the 510(k) pathway. These media and transport solutions are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
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