Omega Medical Diagnostics
Country not established
- Devices
- 5
What Omega Medical Diagnostics makes
Omega Medical Diagnostics manufactures laboratory reagents, including diluents, sodium hypochlorite solutions (3% and 7%), lysing reagents, and hemoglobin reagents. These products are designed for use in blood sample preparation, cell lysis, and hemoglobin analysis in clinical diagnostics.
The company’s portfolio includes Class I and Class II devices, with some products listed via the FDA’s 510(k) pathway. These reagents are intended for in vitro diagnostic use and are regulated under US medical device classifications. The manufacturer operates from the United States.
Catalogue
Diluent Ref K831617
Regimes: 510(k) Registry: 510(k)Sodium Hypochlorite 3% Ref K831620
Regimes: 510(k) Registry: 510(k)Lysing Reagent Ref K832182
Regimes: 510(k) Registry: 510(k)Hemoglobin Reagent Ref K831618
Regimes: 510(k) Registry: 510(k)Sodium Hypochlorite 7% Ref K831619
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Omega Medical Diagnostics have in the registry?
The registry currently lists 5 devices for Omega Medical Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Omega Medical Diagnostics's devices?
Among its 5 most recently registered devices, Omega Medical Diagnostics has devices listed in FDA 510(k) (5 devices).
What risk classes do Omega Medical Diagnostics's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Omega Medical Diagnostics's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Omega Medical Diagnostics in the registry?
The most recently registered devices listed for Omega Medical Diagnostics include DILUENT, SODIUM HYPOCHLORITE 3%, LYSING REAGENT and HEMOGLOBIN REAGENT.