Avanti Polar Lipids, Inc.
Country not established
- Devices
- 1
What Avanti Polar Lipids, Inc. makes
Avanti Polar Lipids, Inc. produces diagnostic reagents, including VDRL antigen slide test kits and bulk BDRL antigen for syphilis testing. These products are designed for use in serological assays to detect antibodies in patient samples.
The company’s portfolio is regulated under FDA’s Class II device classification, with relevant products authorised via the 510(k) pathway. These products are 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 Avanti Polar Lipids, Inc. have in the registry?
The registry currently lists 1 device for Avanti Polar Lipids, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Avanti Polar Lipids, Inc.'s devices?
Among its 1 most recently registered device, Avanti Polar Lipids, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Avanti Polar Lipids, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Avanti Polar Lipids, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Avanti Polar Lipids, Inc. in the registry?
The most recently registered devices listed for Avanti Polar Lipids, Inc. include AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI.