Amtec Diagnostics International, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Amtec Diagnostics International, Inc. makes
Amtec Diagnostics International, Inc. produces in vitro diagnostic tests for detecting acute phase C-reactive protein and rheumatoid factor using latex agglutination methods.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Acute Phase C-Reactive Protein Latex Agglu. Test Ref K882998
Regimes: 510(k) Registry: 510(k)Amtec Rheumatoid Factor Latex Agglutination Kit Ref K873064
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Amtec Diagnostics International, Inc. have in the registry?
The registry currently lists 2 devices for Amtec Diagnostics International, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Amtec Diagnostics International, Inc.'s devices?
Among its 2 most recently registered devices, Amtec Diagnostics International, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Amtec Diagnostics International, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Amtec Diagnostics International, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Amtec Diagnostics International, Inc. in the registry?
The most recently registered devices listed for Amtec Diagnostics International, Inc. include ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST and AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT.