Worthington Diagnostic Systems
Country not established
- Devices
- 19
What Worthington Diagnostic Systems makes
Worthington Diagnostic Systems manufactures diagnostic reagents and calibrators for laboratory testing, including hemoglobin, blood urea nitrogen (BUN), triglycerides, thyroid hormones, and coagulation factors. Their portfolio also includes enzyme immunoassay reagents for serum T4 and reagents for measuring uric acid, creatinine kinase (CK), and total bilirubin. The company produces both standalone reagents and reagent sets designed for use with automated chemistry analyzers.
The company’s products are regulated under the FDA’s 510(k) pathway, with devices classified primarily as Class I and Class II. These reagents and analyzers are listed with the U.S. Food and Drug Administration, adhering to regulatory requirements for in vitro diagnostics. The manufacturer operates from the United States.
Catalogue
Search and filter all 19 devicesFrequently asked questions
How many devices does Worthington Diagnostic Systems have in the registry?
The registry currently lists 19 devices for Worthington Diagnostic Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Worthington Diagnostic Systems's devices?
Among its 19 most recently registered devices, Worthington Diagnostic Systems has devices listed in FDA 510(k) (19 devices).
What risk classes do Worthington Diagnostic Systems's devices fall under?
Among its 19 most recently registered devices, the classes recorded for Worthington Diagnostic Systems's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Worthington Diagnostic Systems in the registry?
The most recently registered devices listed for Worthington Diagnostic Systems include EASYTOUCH HEMOGLOBIN REAGENT, EASYTOUCH BUN REAGENT SET, TIA-IGA REAGENT & CALIBRATOR SETS and SZAMYL 6.5.