Innotron Diagnostics
Country not established
- Devices
- 6
What Innotron Diagnostics makes
Innotron Diagnostics manufactures fluorescent diagnostic reagents for therapeutic drug monitoring, including INNOFLUOR PRIMIDONE, INNOFLUOR TOBRAMYCIN, INNOFLUOR PHENOBARBITAL, INNOFLUOR GENTAMICIN, INNOFLUOR THEOPHYLLINE, and INNOFLUOR PHENYTOIN. These products are designed for use in clinical laboratories to detect and quantify specific drugs in patient samples, supporting precision dosing in pharmacotherapy.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with products listed via the 510(k) pathway. These reagents are intended for in vitro diagnostic use and are registered with the FDA. The manufacturer operates from the United States.
Catalogue
Innofluor Primidone Ref K844721
Regimes: 510(k) Registry: 510(k)Innoflour Tobramycin Ref K841866
Regimes: 510(k) Registry: 510(k)Innofluor Phenobarbital Ref K841707
Regimes: 510(k) Registry: 510(k)Innoflour Gentamicin Ref K841865
Regimes: 510(k) Registry: 510(k)Innofluor Theophylline Ref K850629
Regimes: 510(k) Registry: 510(k)Innofluor Phenytoin Ref K841706
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Innotron Diagnostics have in the registry?
The registry currently lists 6 devices for Innotron Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Innotron Diagnostics's devices?
Among its 6 most recently registered devices, Innotron Diagnostics has devices listed in FDA 510(k) (6 devices).
What risk classes do Innotron Diagnostics's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Innotron Diagnostics's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Innotron Diagnostics in the registry?
The most recently registered devices listed for Innotron Diagnostics include INNOFLUOR PRIMIDONE, INNOFLOUR TOBRAMYCIN, INNOFLUOR PHENOBARBITAL and INNOFLOUR GENTAMICIN.