Research Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Research Diagnostics, Inc. makes
Research Diagnostics, Inc. manufactures diagnostic test kits for measuring human IgG subclasses, including ELISA combi kits, nephelometric BNA kits, and RID combi kits (modified). These products are designed for laboratory use to quantify specific antibody levels in serum or plasma samples.
The company’s diagnostic kits fall under FDA Class I devices and are listed via 510(k) clearance in the United States. No additional regulatory bodies or classifications are referenced for these products.
Catalogue
Human Igg Subclasses Elisa Combi Kit Ref K943098
Regimes: 510(k) Registry: 510(k)Human Igg Subclasses Nephelometric Bna Kit Ref K944876
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Research Diagnostics, Inc. have in the registry?
The registry currently lists 3 devices for Research Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Research Diagnostics, Inc.'s devices?
Among its 3 most recently registered devices, Research Diagnostics, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Research Diagnostics, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Research Diagnostics, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Research Diagnostics, Inc. in the registry?
The most recently registered devices listed for Research Diagnostics, Inc. include HUMAN IGG SUBCLASSES ELISA COMBI KIT, HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT and HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION).