Reagents Applications, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 63
What Reagents Applications, Inc. makes
Reagents Applications, Inc. manufactures diagnostic reagents for clinical chemistry testing, including enzymatic and colorimetric assays for analytes such as creatine kinase, acid phosphatase, uric acid, triglycerides, albumin, glucose, hemoglobin, and immunoglobulins (IgM, IgA, Apo B, Apo A-1, and C3). Their portfolio also includes specialized reagents for spectrophotometric and immunochemical measurements, such as UV-based and enzyme-linked assays.
The company’s diagnostic reagents are classified under FDA’s Class I and Class II categories, with regulatory submissions supported by 510(k) clearances. These products are intended for in vitro use in laboratory settings and are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Search and filter all 63 devicesShowing 1-50 of 63
Frequently asked questions
How many devices does Reagents Applications, Inc. have in the registry?
The registry currently lists 63 devices for Reagents Applications, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Reagents Applications, Inc.'s devices?
Among its 50 most recently registered devices, Reagents Applications, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Reagents Applications, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Reagents Applications, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Reagents Applications, Inc. in the registry?
The most recently registered devices listed for Reagents Applications, Inc. include TOTAL PROTEIN REAGENT BIURET, RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV, RAICHEM ACID PHASPHATASE REAGENT and RAICHEM(TM) SPIA(TM) APO B REAGENTS.