Sclavo, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 82
What Sclavo, Inc. makes
Sclavo, Inc. manufactures diagnostic reagents and assay kits for clinical laboratory testing, including enzymatic single-reagent tests for cholesterol, acid phosphatase, creatine phosphokinase (CPK), and uric acid. Their portfolio also covers coated tube reagents for phenobarbital and theophylline assays, as well as kinetic and UV-based tests for liver enzymes (AST/GOT, ALT/GPT) and alkaline phosphatase. Additional offerings include chloride testing reagents and a CPK-MB diagnostic kit for cardiac marker analysis.
The company’s diagnostic products are classified under FDA’s Class I and Class II categories, with regulatory submissions supported via 510(k) clearances. These devices are intended for in vitro diagnostic use and are listed in the FDA’s 510(k) registry. The manufacturer operates from the United States.
Catalogue
Search and filter all 82 devicesShowing 1-50 of 82
Frequently asked questions
How many devices does Sclavo, Inc. have in the registry?
The registry currently lists 82 devices for Sclavo, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sclavo, Inc.'s devices?
Among its 50 most recently registered devices, Sclavo, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Sclavo, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Sclavo, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sclavo, Inc. in the registry?
The most recently registered devices listed for Sclavo, Inc. include C-REACTIVE PROTEIN TEST KIT, ISOENZYME TEST CK-MB, NEW ENZYMATIC SINGLE REAGENT FREE CHOL. and ACP KINETIC TEST (ACID PHOSPHATASE TEST).