Schiapparelli Biosystems, Inc.
United StatesFDA applicant, unverified
- Devices
- 24
What Schiapparelli Biosystems, Inc. makes
Schiapparelli Biosystems, Inc. manufactures clinical chemistry reagents and calibrators for laboratory testing, including ACE PRIMIDONE, TRIGLYCERIDES, ACE HDL-C, ACE LDL-C, and ACE VALPROIC ACID reagents. Their portfolio also covers specialized assays like ACE(TM) CEDIA(R) PHENYTOIN and FERRITIN, as well as calibrators and controls for antiepileptic drugs (AEDs). The company produces reagents for ion-selective electrodes and a clinical chemistry system designed for automated laboratory analysis.
The company’s products are regulated under FDA’s 510(k) premarket notification process, with devices classified as Class I and Class II. Their reagents and systems are listed in the FDA’s 510(k) registry, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 24 devicesFrequently asked questions
How many devices does Schiapparelli Biosystems, Inc. have in the registry?
The registry currently lists 24 devices for Schiapparelli Biosystems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Schiapparelli Biosystems, Inc.'s devices?
Among its 24 most recently registered devices, Schiapparelli Biosystems, Inc. has devices listed in FDA 510(k) (24 devices).
What risk classes do Schiapparelli Biosystems, Inc.'s devices fall under?
Among its 24 most recently registered devices, the classes recorded for Schiapparelli Biosystems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Schiapparelli Biosystems, Inc. in the registry?
The most recently registered devices listed for Schiapparelli Biosystems, Inc. include ACE PRIMIDONE REAGENT, AED CALIBRATORS, TRIGLYCERIDES REAGENT, ACE HDL-C REAGENT and ACE CLINICAL CHEMISTRY SYSTEM.