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
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