Macomb Biotechnology, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Macomb Biotechnology, Inc. makes
Macomb Biotechnology, Inc. manufactures reagent sets for laboratory use, including a uric acid reagent set and a modified hemoglobin reagent set. These products are designed for diagnostic testing in clinical settings to measure specific biochemical parameters in patient samples.
The company’s portfolio includes Class I and Class II devices, with some products authorised via the FDA’s 510(k) pathway. These reagent sets are listed under U.S. regulatory requirements, and the manufacturer operates from the United States.
Catalogue
The Uric Acid Reagent Set Ref K871902
Regimes: 510(k) Registry: 510(k)Modified Hemoglobin Reagent Set Ref K894951
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Macomb Biotechnology, Inc. have in the registry?
The registry currently lists 2 devices for Macomb Biotechnology, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Macomb Biotechnology, Inc.'s devices?
Among its 2 most recently registered devices, Macomb Biotechnology, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Macomb Biotechnology, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Macomb Biotechnology, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Macomb Biotechnology, Inc. in the registry?
The most recently registered devices listed for Macomb Biotechnology, Inc. include THE URIC ACID REAGENT SET and MODIFIED HEMOGLOBIN REAGENT SET.