Labco, Ltd.
US Last updated 23 May 2026
- Devices
- 1
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
Labco Limited Exetainer(R) Ref K880622
FDA establishments
- Labco Limited GB
What Labco, Ltd. makes
Labco, Ltd. manufactures the Exetainer, a device designed for the collection, storage, and transport of blood or other biological samples, ensuring integrity and stability for laboratory analysis.
The Exetainer is classified as a Class II medical device in the United States and is listed under the FDA’s 510(k) clearance process. The company is based in the US.
Frequently asked questions
What types of medical devices does Labco, Ltd. manufacture?
Labco, Ltd. specializes in devices for handling biological samples. Specifically, they produce the Exetainer, which is designed for the collection, storage, and transport of blood or other biological specimens. This ensures sample integrity and stability during laboratory analysis.
Where is Labco, Ltd. based?
Labco, Ltd. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with US medical device standards.
How are Labco, Ltd.’s devices classified in the US?
Labco, Ltd.’s Exetainer is classified as a Class II medical device in the United States. This classification is determined by the FDA based on factors like the device’s intended use, potential risks, and the need for special controls to ensure safety and effectiveness. Class II devices generally require premarket notification (510(k)) clearance before commercial distribution.
Which regulatory registries or databases list Labco, Ltd.’s devices?
Labco, Ltd.’s Exetainer is listed under the FDA’s 510(k) clearance process, meaning it has undergone premarket notification review to demonstrate substantial equivalence to a legally marketed predicate device. This registration is part of the FDA’s database for Class II devices in the US.
Information
- Country
- US