Rhigene, Inc.
United StatesFDA applicant, unverified
- Devices
- 15
What Rhigene, Inc. makes
Rhigene, Inc. manufactures enzyme-linked immunosorbent assay (ELISA) test systems and lateral flow immunoassay devices for detecting specific antibodies and antigens, including anti-mitochondrial antibodies (M2), anti-nuclear antibodies (RNP, CENP-B, SM), and anti-neutrophil cytoplasmic antibodies (MPO). Their portfolio includes the MESACUP-2 and DSG-1/DSG-3 test kits, as well as nucleic acid detection systems for imaging applications.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company’s products are listed in the FDA’s 510(k) registry, adhering to US medical device compliance standards. Rhigene, Inc. is headquartered in the United States.
Catalogue
Search and filter all 15 devicesFrequently asked questions
How many devices does Rhigene, Inc. have in the registry?
The registry currently lists 15 devices for Rhigene, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rhigene, Inc.'s devices?
Among its 15 most recently registered devices, Rhigene, Inc. has devices listed in FDA 510(k) (15 devices).
What risk classes do Rhigene, Inc.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for Rhigene, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Rhigene, Inc. in the registry?
The most recently registered devices listed for Rhigene, Inc. include RHIGENE MESACUP2 TEST- SSB, RHIGENE MESACUP2 TEST- SCL-70, RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 and RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E.