Integrated Biotechnology Corp.
Country not established
- Devices
- 1
What Integrated Biotechnology Corp. makes
Integrated Biotechnology Corp. manufactures the QUICKLAB RSV, a rapid diagnostic test designed for the detection of respiratory syncytial virus (RSV) infections. This device is intended for point-of-care use in clinical settings to provide quick results for patient management.
The QUICKLAB RSV falls under Class I medical devices in the United States and is listed under the FDA’s 510(k) pathway. The company operates from the US, adhering to applicable regulatory requirements for diagnostic testing devices.
Catalogue
Quicklab Rsv Ref K021789
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Integrated Biotechnology Corp. have in the registry?
The registry currently lists 1 device for Integrated Biotechnology Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Integrated Biotechnology Corp.'s devices?
Among its 1 most recently registered device, Integrated Biotechnology Corp. has devices listed in FDA 510(k) (1 device).
What risk classes do Integrated Biotechnology Corp.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Integrated Biotechnology Corp.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Integrated Biotechnology Corp. in the registry?
The most recently registered devices listed for Integrated Biotechnology Corp. include QUICKLAB RSV.