Dako Diagnostics, Ltd.
United KingdomFDA applicant, unverified
- Devices
- 6
What Dako Diagnostics, Ltd. makes
Dako Diagnostics produces rapid diagnostic tests for respiratory pathogens, including assays for rotavirus, influenza virus groups, parainfluenza virus types 1–3, and respiratory screen panels. The IMAGEN platform supports visual detection of these viral targets in clinical samples, while IDEIA reagents are used for chlamydia testing modifications.
These devices are classified as Class I under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States, with its products listed in the FDA’s 510(k) registry.
Catalogue
Imagen Ref K943557
Regimes: 510(k) Registry: 510(k)Ideia(Tm) Rotavirus Ref K932384
Regimes: 510(k) Registry: 510(k)Imagearainfluenza Virus Group (Types 1, 2 And 3) Test And Imagen Parainfluenza Virus Test Types 1, 2 And 3 Ref K981226
Regimes: 510(k) Registry: 510(k)Imagen Respiratory Screen Ref K962037
Regimes: 510(k) Registry: 510(k)Imagen Respiratory Screen Ref K973954
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dako Diagnostics, Ltd. have in the registry?
The registry currently lists 6 devices for Dako Diagnostics, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dako Diagnostics, Ltd.'s devices?
Among its 6 most recently registered devices, Dako Diagnostics, Ltd. has devices listed in FDA 510(k) (6 devices).
What risk classes do Dako Diagnostics, Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Dako Diagnostics, Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Dako Diagnostics, Ltd. in the registry?
The most recently registered devices listed for Dako Diagnostics, Ltd. include IMAGEN, IDEIA(TM) ROTAVIRUS, IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1, 2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1, 2 AND 3 and IMAGEN RESPIRATORY SCREEN.