Ac Biochemical Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Ac Biochemical Laboratories, Inc. makes
Ac Biochemical Laboratories, Inc. manufactures diagnostic reagents for in vitro testing, including uric acid, cholesterol, and glucose assays. These products are designed for laboratory use to measure specific analytes in patient samples, supporting clinical diagnostics.
The company’s portfolio includes Class I and Class II devices, with some products cleared via the FDA’s 510(k) pathway. These reagents are listed under U.S. regulatory requirements and are intended for use in accredited laboratories.
Catalogue
Uric Acid Reagent Ref K822913
Regimes: 510(k) Registry: 510(k)Cholesterol Reagent Ref K823500
Regimes: 510(k) Registry: 510(k)Glucose Reagent Ref K823537
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ac Biochemical Laboratories, Inc. have in the registry?
The registry currently lists 3 devices for Ac Biochemical Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ac Biochemical Laboratories, Inc.'s devices?
Among its 3 most recently registered devices, Ac Biochemical Laboratories, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Ac Biochemical Laboratories, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Ac Biochemical Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ac Biochemical Laboratories, Inc. in the registry?
The most recently registered devices listed for Ac Biochemical Laboratories, Inc. include URIC ACID REAGENT, CHOLESTEROL REAGENT and GLUCOSE REAGENT.