Biological & Diagnostic Products
Country not established
- Devices
- 1
What Biological & Diagnostic Products makes
The company manufactures the ZETAPHASE-DIG, a diagnostic device designed for detecting specific biological markers or pathogens in clinical samples, likely using phase-based detection technology.
This product is classified as a Class II medical device under FDA regulations and is authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Zetaphase-Dig Ref K822053
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biological & Diagnostic Products have in the registry?
The registry currently lists 1 device for Biological & Diagnostic Products. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biological & Diagnostic Products's devices?
Among its 1 most recently registered device, Biological & Diagnostic Products has devices listed in FDA 510(k) (1 device).
What risk classes do Biological & Diagnostic Products's devices fall under?
Among its 1 most recently registered device, the classes recorded for Biological & Diagnostic Products's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biological & Diagnostic Products in the registry?
The most recently registered devices listed for Biological & Diagnostic Products include ZETAPHASE-DIG.