Kodak Clinical Diagnostics, Ltd.
United KingdomFDA applicant, unverified
- Devices
- 1
What Kodak Clinical Diagnostics, Ltd. makes
Kodak Clinical Diagnostics, Ltd. manufactures the AMERLITE MAB FT4 ASSAY, a diagnostic test designed to measure free thyroxine (FT4) levels in blood serum or plasma using a chemiluminescent microparticle immunoassay method.
The AMERLITE MAB FT4 ASSAY is classified as a Class II medical device in the United States and is listed under the FDA’s 510(k) premarket notification process. The company is based in the US.
Catalogue
Amerlite Mab FT4 Assay Ref K955097
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Kodak Clinical Diagnostics, Ltd. have in the registry?
The registry currently lists 1 device for Kodak Clinical Diagnostics, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kodak Clinical Diagnostics, Ltd.'s devices?
Among its 1 most recently registered device, Kodak Clinical Diagnostics, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Kodak Clinical Diagnostics, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Kodak Clinical Diagnostics, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kodak Clinical Diagnostics, Ltd. in the registry?
The most recently registered devices listed for Kodak Clinical Diagnostics, Ltd. include AMERLITE MAB FT4 ASSAY.