Skd, Inc. A Beckman Coulter Co.
Country not established
- Devices
- 1
What Skd, Inc. A Beckman Coulter Co. makes
Skd, Inc. manufactures rapid diagnostic tests for detecting human chorionic gonadotropin (hCG) in urine and serum samples, including models designed for point-of-care and clinical laboratory use. These devices are intended for pregnancy testing and related medical evaluations, providing qualitative results to aid in diagnostic decision-making.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) clearance process. These devices are listed in the FDA’s 510(k) database, adhering to US regulatory standards for in vitro diagnostics. The manufacturer operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Skd, Inc. A Beckman Coulter Co. have in the registry?
The registry currently lists 1 device for Skd, Inc. A Beckman Coulter Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Skd, Inc. A Beckman Coulter Co.'s devices?
Among its 1 most recently registered device, Skd, Inc. A Beckman Coulter Co. has devices listed in FDA 510(k) (1 device).
What risk classes do Skd, Inc. A Beckman Coulter Co.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Skd, Inc. A Beckman Coulter Co.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Skd, Inc. A Beckman Coulter Co. in the registry?
The most recently registered devices listed for Skd, Inc. A Beckman Coulter Co. include ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025, 40050, 40005 & 41025.