Wortham Laboratories, Inc.
Country not established
- Devices
- 1
What Wortham Laboratories, Inc. makes
Wortham Laboratories, Inc. manufactures laboratory controls and reagents, including STASIS (I, II, III), SERATHAN (A, B), and INTRIN calcium chloride solutions (0.02M), as well as fibrinogen controls (normal and low) for coagulation testing.
These products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Wortham Laboratories, Inc. have in the registry?
The registry currently lists 1 device for Wortham Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wortham Laboratories, Inc.'s devices?
Among its 1 most recently registered device, Wortham Laboratories, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Wortham Laboratories, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Wortham Laboratories, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Wortham Laboratories, Inc. in the registry?
The most recently registered devices listed for Wortham Laboratories, Inc. include STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW.