Crestat Diagnostics, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 29
What Crestat Diagnostics, Inc. makes
Crestat Diagnostics, Inc. manufactures in vitro diagnostic reagents and test kits for clinical laboratory use, including calibrator sets for C-reactive protein (CRP), microalbumin, and glucose, as well as immunoassay reagents for immunoglobulin G (IgM, IgA) and enzyme-based assays for creatine phosphokinase (CPK-L), aspartate aminotransferase (AST/GOT), direct bilirubin (D-BIL), and plasminogen. The company also produces specialized test kits for C1-inhibitor and CRP detection, designed for automated immunoassay systems.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded via the 510(k) pathway. These products are intended for use in the United States, where Crestat Diagnostics is based.
Catalogue
Search and filter all 29 devicesFrequently asked questions
How many devices does Crestat Diagnostics, Inc. have in the registry?
The registry currently lists 29 devices for Crestat Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Crestat Diagnostics, Inc.'s devices?
Among its 29 most recently registered devices, Crestat Diagnostics, Inc. has devices listed in FDA 510(k) (29 devices).
What risk classes do Crestat Diagnostics, Inc.'s devices fall under?
Among its 29 most recently registered devices, the classes recorded for Crestat 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 Crestat Diagnostics, Inc. in the registry?
The most recently registered devices listed for Crestat Diagnostics, Inc. include N-ASSAY TIA MULTI CRP CALIBRATOR SET, N-ASSAY TIA IGM, N-ASSAY CPK-L and N-ASSAY TIA IGA.