Immuno-U.S., Inc.
Country not established
- Devices
- 1
What Immuno-U.S., Inc. makes
Immuno-U.S., Inc. manufactures prefilled syringe devices under the DUPLOJECT brand, available in 0.5 mL, 1.0 mL, 2.0 mL, and 5.0 mL volumes. These are designed for single-use injection of liquid medications, including biologics and small-molecule drugs, with integrated needle protection and a user-friendly design for subcutaneous or intramuscular administration.
The company’s products fall under FDA Class II regulatory classification and are listed via 510(k) clearance. The devices are intended for use in the United States, where compliance with FDA requirements applies. No additional registries or international authorisations are referenced.
Catalogue
Duploject (0.5/1.0 Ml, 2.0 Ml, 5.0 Ml) Ref K973510
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Immuno-U.S., Inc. have in the registry?
The registry currently lists 1 device for Immuno-U.S., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Immuno-U.S., Inc.'s devices?
Among its 1 most recently registered device, Immuno-U.S., Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Immuno-U.S., Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Immuno-U.S., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Immuno-U.S., Inc. in the registry?
The most recently registered devices listed for Immuno-U.S., Inc. include DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML).