Immuno-Diagnostic Laboratories
Country not established
- Devices
- 2
What Immuno-Diagnostic Laboratories makes
Immuno-Diagnostic Laboratories manufactures laboratory reagents and columns for biochemical assays, including the CEA desalting column (Sephadex R) used in immunoassay sample preparation and the angiotensin-converting enzyme reagent for diagnostic testing.
These products are classified as Class II medical devices under FDA regulations and are recorded in the 510(k) premarket notification database. The company operates from the United States.
Catalogue
Cea Desalting Dolumn Sephadex R Ref K811394
Regimes: 510(k) Registry: 510(k)Angiotensin Converting Enzyme Ref K833777
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Immuno-Diagnostic Laboratories have in the registry?
The registry currently lists 2 devices for Immuno-Diagnostic Laboratories. Devices recorded under merged duplicate company entries are counted once.
Which registries list Immuno-Diagnostic Laboratories's devices?
Among its 2 most recently registered devices, Immuno-Diagnostic Laboratories has devices listed in FDA 510(k) (2 devices).
What risk classes do Immuno-Diagnostic Laboratories's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Immuno-Diagnostic Laboratories's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Immuno-Diagnostic Laboratories in the registry?
The most recently registered devices listed for Immuno-Diagnostic Laboratories include CEA DESALTING DOLUMN SEPHADEX R and ANGIOTENSIN CONVERTING ENZYME.