Health Research, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Health Research, Inc. makes
Health Research, Inc. manufactures latex-based diagnostic reagents for serological testing, including antigens for *Salmonella Typhi*, *Rickettsia rickettsii*, and *Rickettsia conorii*. These products are designed for use in agglutination assays to detect corresponding antibodies in patient sera.
The company’s portfolio is classified under FDA’s Class I regulatory category and is listed via 510(k) premarket notifications. The products are intended for in vitro diagnostic use and comply with US regulatory requirements.
Catalogue
Latex R. Typhi Ref K860557
Regimes: 510(k) Registry: 510(k)Latex-R Rickettsii Ref K843794
Regimes: 510(k) Registry: 510(k)Latex R. Conorii Ref K872129
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Health Research, Inc. have in the registry?
The registry currently lists 3 devices for Health Research, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Health Research, Inc.'s devices?
Among its 3 most recently registered devices, Health Research, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Health Research, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Health Research, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Health Research, Inc. in the registry?
The most recently registered devices listed for Health Research, Inc. include LATEX R. TYPHI, LATEX-R RICKETTSII and LATEX R. CONORII.