Boditech Diagnostics, Inc.
Country not established
- Devices
- 1
What Boditech Diagnostics, Inc. makes
Boditech Diagnostics, Inc. manufactures the I-CHROMA CRP test, a lateral flow immunoassay for the qualitative detection of C-reactive protein (CRP) in whole blood, serum, or plasma. This device is designed for point-of-care use to aid in the diagnosis of bacterial infections and inflammatory conditions.
The I-CHROMA CRP test is classified as a Class II medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
I-Chroma Crp Test Ref K062981
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Boditech Diagnostics, Inc. have in the registry?
The registry currently lists 1 device for Boditech Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Boditech Diagnostics, Inc.'s devices?
Among its 1 most recently registered device, Boditech Diagnostics, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Boditech Diagnostics, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Boditech Diagnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Boditech Diagnostics, Inc. in the registry?
The most recently registered devices listed for Boditech Diagnostics, Inc. include I-CHROMA CRP TEST.