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
Search and filter all 93 devicesShowing 1-50 of 93
Frequently asked questions
How many devices does Isle Media and Sterile Products, Inc. have in the registry?
The registry currently lists 93 devices for Isle Media and Sterile Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Isle Media and Sterile Products, Inc.'s devices?
Among its 50 most recently registered devices, Isle Media and Sterile Products, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Isle Media and Sterile Products, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Isle Media and Sterile Products, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Isle Media and Sterile Products, Inc. in the registry?
The most recently registered devices listed for Isle Media and Sterile Products, Inc. include BRAIN HEART INFUSION AGAR, KF STREPTOCOCCUS AGAR, MANNITOL SALT AGAR and MUELLER HINTON AGARS.