Siemens Healthcare Disgnostics, Inc.
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- Devices
- 1
What Siemens Healthcare Disgnostics, Inc. makes
Siemens Healthcare Diagnostics, Inc. manufactures the ADVIA Centaur CEA Assay, a laboratory immunoassay system designed to quantify carcinoembryonic antigen (CEA) levels in blood samples. This device is used primarily for monitoring patients with colorectal cancer and other conditions where CEA levels may be clinically relevant.
The ADVIA Centaur CEA Assay is classified as a Class II medical device under FDA regulations and has been authorised through the 510(k) clearance process. The company is based in the United States.
Catalogue
ADVIA Centaur CEA Assay Ref K200215
Regimes: CE IVDR 510(k) Registry: EUDAMED510(k)GUDID
Frequently asked questions
How many devices does Siemens Healthcare Disgnostics, Inc. have in the registry?
The registry currently lists 1 device for Siemens Healthcare Disgnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Siemens Healthcare Disgnostics, Inc.'s devices?
Among its 1 most recently registered device, Siemens Healthcare Disgnostics, Inc. has devices listed in EUDAMED (1 device), FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Siemens Healthcare Disgnostics, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Siemens Healthcare Disgnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Siemens Healthcare Disgnostics, Inc. in the registry?
The most recently registered devices listed for Siemens Healthcare Disgnostics, Inc. include ADVIA Centaur CEA Assay.