Specialized Assays, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Specialized Assays, Inc. makes
Specialized Assays, Inc. manufactures enzyme linearity test sets, including the STABLELIN ENZYME LINEARITY TEST SET A, B, and C. These products are designed to validate and verify the performance of enzyme-based assays across a defined range of concentrations, ensuring accuracy in laboratory testing.
The company’s portfolio is classified under FDA Class I devices and is listed via the 510(k) pathway. These products are intended for use in the United States, where regulatory compliance is required for commercial distribution.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Specialized Assays, Inc. have in the registry?
The registry currently lists 3 devices for Specialized Assays, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Specialized Assays, Inc.'s devices?
Among its 3 most recently registered devices, Specialized Assays, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Specialized Assays, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Specialized Assays, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Specialized Assays, Inc. in the registry?
The most recently registered devices listed for Specialized Assays, Inc. include STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003), STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002) and STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001).