Granite Diagnostics, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 47
What Granite Diagnostics, Inc. makes
Granite Diagnostics, Inc. manufactures microbiological culture media and diagnostic agar plates for identifying and isolating bacteria, fungi, and other microorganisms. Products include selective and differential media such as DNAse Test Agar with Toluidine Blue, Campylobacter Medium, and Yeast Assimilation Broth, as well as specialized plates like Middlebrook 7H11 Agar for mycobacterial growth and Litman Oxgall Agar for enteric pathogen detection.
The company’s portfolio includes both Class I and Class II medical devices, with submissions recorded under the FDA’s 510(k) clearance pathway. These products are intended for in vitro diagnostic use and are listed in the FDA’s regulatory database. The manufacturer is based in the United States.
Catalogue
Search and filter all 47 devicesFrequently asked questions
How many devices does Granite Diagnostics, Inc. have in the registry?
The registry currently lists 47 devices for Granite Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Granite Diagnostics, Inc.'s devices?
Among its 47 most recently registered devices, Granite Diagnostics, Inc. has devices listed in FDA 510(k) (47 devices).
What risk classes do Granite Diagnostics, Inc.'s devices fall under?
Among its 47 most recently registered devices, the classes recorded for Granite Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Granite Diagnostics, Inc. in the registry?
The most recently registered devices listed for Granite Diagnostics, Inc. include DNASE TEST AGAR W/TOLUIDINE BLUE, LSM AGAR, MIDDLEBROOK 7H11 AGAR (PLATE) and YEAST ASSIMILATION BROTH.