Vital Diagnostics (Manufacturing) Ptyltd
Country not established
- Devices
- 5
What Vital Diagnostics (Manufacturing) Ptyltd makes
Vital Diagnostics manufactures in vitro diagnostic reagents and calibrators, including calcium reagents, serum calibrators for direct bilirubin and iron, and creatine phosphokinase (CPK) reagents. The company also produces chemistry analyzers, such as the EON 100 with ion-selective electrode (ISE) functionality, along with bicarbonate reagents and serum controls for laboratory use.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with several products authorised via the 510(k) pathway. These products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Eon Calcium Regent Ref K120626
510(k) 510(k)- 510(k) 510(k)
Cpk Reagent Ref K112416
510(k) 510(k)- 510(k) 510(k)
Vital Serum Controls Ref K111063
510(k) 510(k)
Frequently asked questions
How many devices does Vital Diagnostics (Manufacturing) Ptyltd have in the registry?
The registry currently lists 5 devices for Vital Diagnostics (Manufacturing) Ptyltd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vital Diagnostics (Manufacturing) Ptyltd's devices?
Among its 5 most recently registered devices, Vital Diagnostics (Manufacturing) Ptyltd has devices listed in FDA 510(k) (5 devices).
What risk classes do Vital Diagnostics (Manufacturing) Ptyltd's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Vital Diagnostics (Manufacturing) Ptyltd's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Vital Diagnostics (Manufacturing) Ptyltd in the registry?
The most recently registered devices listed for Vital Diagnostics (Manufacturing) Ptyltd include EON CALCIUM REGENT, ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON), CPK REAGENT and EON 100 CHEMISTRY ANALYZER WITH ISE, MODEL 77105, BICARBONATE REAGENT, MODEL 77475.