Biochemical Trade, Inc.
United StatesFDA applicant, unverified
- Devices
- 20
What Biochemical Trade, Inc. makes
Biochemical Trade, Inc. manufactures diagnostic reagent kits and test systems for laboratory analysis, including colorimetric and ultraviolet-based assays for glucose, creatinine, blood urea nitrogen (BUN), albumin, cholesterol, enzymes (such as creatine kinase, alkaline phosphatase, and gamma-glutamyl transferase), bilirubin, uric acid, phosphorus, and transaminases (AST/GOT). These products are designed for in vitro biochemical measurements in clinical settings.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the 510(k) clearance registry. The products are intended for use in the United States, where regulatory compliance follows FDA guidelines for in vitro diagnostic (IVD) devices.
Catalogue
Search and filter all 20 devicesFrequently asked questions
How many devices does Biochemical Trade, Inc. have in the registry?
The registry currently lists 20 devices for Biochemical Trade, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biochemical Trade, Inc.'s devices?
Among its 20 most recently registered devices, Biochemical Trade, Inc. has devices listed in FDA 510(k) (20 devices).
What risk classes do Biochemical Trade, Inc.'s devices fall under?
Among its 20 most recently registered devices, the classes recorded for Biochemical Trade, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biochemical Trade, Inc. in the registry?
The most recently registered devices listed for Biochemical Trade, Inc. include GLUCOSE ENZYME - COLOR REAGENT SET, CREATINE KINASE MB DETERMINATION (UV), COLORIMETRIC BUN REAGENT KIT and ULTRA-VIOLET GLUCOSE REAGENT KIT.