Amico Laboratories, Inc.
Country not established
- Devices
- 1
What Amico Laboratories, Inc. makes
Amico Laboratories, Inc. manufactures the AMIZYME Epstein-Barr Virus (EBV) IgM Antibody Test, a diagnostic in vitro device used to detect IgM antibodies against EBV in human serum or plasma.
This product is classified as a Class I medical device under FDA regulations and is listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Amico Laboratories, Inc. have in the registry?
The registry currently lists 1 device for Amico Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Amico Laboratories, Inc.'s devices?
Among its 1 most recently registered device, Amico Laboratories, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Amico Laboratories, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Amico Laboratories, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Amico Laboratories, Inc. in the registry?
The most recently registered devices listed for Amico Laboratories, Inc. include AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST.