Alere Inc.
Country not established
- Devices
- 8
What Alere Inc. makes
Alere Inc. manufactures the AFP RIA Kit, a diagnostic test designed for the quantitative measurement of alpha-fetoprotein (AFP) in serum or plasma using radioimmunoassay technology. This product is intended for clinical use in monitoring conditions such as hepatocellular carcinoma and other liver-related disorders.
The AFP RIA Kit is classified as a Class III medical device under FDA regulations and is listed under a Premarket Approval Application (PMA). The company is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Afp Ria Kit Ref P760001
Regimes: PMA, withdrawn Registry: PMA
Company details
- DUNS number
- 093803398
Frequently asked questions
How many devices does ALERE INC. have in the registry?
The registry currently lists 8 devices for ALERE INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ALERE INC.'s devices?
Among its 8 most recently registered devices, ALERE INC. has devices listed in FDA PMA (1 device) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ALERE INC.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for ALERE INC.'s devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from ALERE INC. in the registry?
The most recently registered devices listed for ALERE INC. include Immunalysis Corporation 219-0096, Immunalysis Corporation FC-219-750, Immunalysis Corporation 219-0480 and Immunalysis Corporation FC-219-60.