Gds Diagnostics
Country not established
- Devices
- 4
What Gds Diagnostics makes
Gds Diagnostics produces enzymatic reagents for laboratory testing, including the ACETASITE reagent for acetazolamide assays and reagents for measuring theophylline and β-hydroxybutyrate levels. It also supplies control and linearity standards for analytical validation in clinical chemistry.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded via the 510(k) pathway. These products are listed in the FDA’s regulatory database and are intended for use in the United States.
Catalogue
Acetasite Ref K931257
Regimes: 510(k) Registry: 510(k)Control And Linearity Ref K910881
Regimes: 510(k) Registry: 510(k)Gds Enzymatic Theophylline Reagent Ref K891761
Regimes: 510(k) Registry: 510(k)Gds Enzymatic B-Hydroxybutyrate Reagent Modified Ref K910108
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gds Diagnostics have in the registry?
The registry currently lists 4 devices for Gds Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gds Diagnostics's devices?
Among its 4 most recently registered devices, Gds Diagnostics has devices listed in FDA 510(k) (4 devices).
What risk classes do Gds Diagnostics's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Gds Diagnostics's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gds Diagnostics in the registry?
The most recently registered devices listed for Gds Diagnostics include ACETASITE, CONTROL AND LINEARITY, GDS ENZYMATIC THEOPHYLLINE REAGENT and GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED.