Syva Co.
Country not established
- Devices
- 448
What Syva Co. makes
Syva Co. manufactures diagnostic reagents and systems for laboratory testing, including calibrators, immunoassay controls, and solid-phase column systems for drug and metabolite analysis. Their portfolio includes assays for ethyl alcohol, cortisol, theophylline, and controlled substances like phenyclidine and methaqualone, as well as a nebulizer for aerosolized medication delivery. The company also produces a rapid one-step test for C-reactive protein (CRP).
The company’s products are regulated under FDA’s Class I, Class II, and Unclassified (U) device classifications, with many cleared via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Search and filter all 448 devicesShowing 1-50 of 448
Frequently asked questions
How many devices does Syva Co. have in the registry?
The registry currently lists 448 devices for Syva Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Syva Co.'s devices?
Among its 50 most recently registered devices, Syva Co. has devices listed in FDA 510(k) (50 devices).
What risk classes do Syva Co.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Syva Co.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Syva Co. in the registry?
The most recently registered devices listed for Syva Co. include C-REACTIVE PROTEIN CONTROL, ETHYL ALCOHOL SERUM CALIBRATOR, MICRO TRAK XL SYSTEM and SYVA SOLID PHASE COLUMNS SYSTEM II.