Syngene, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Syngene, Inc. makes
Syngene, Inc. manufactures rapid diagnostic tests for detecting Mycobacterium tuberculosis complex and Mycobacterium avium complex, including the SNAP M. TUBERCULOSIS COMPLEX and SNAP MYCOBACTERIA AVIUM COMPLEX assays. These tests are designed for point-of-care use to identify specific bacterial infections in clinical settings.
The company’s diagnostic tests fall under FDA Class I devices and are listed via the 510(k) pathway. These products are intended for use in the United States, where regulatory compliance is managed through the FDA’s premarket notification process.
Catalogue
Snap M. Tuberculosis Complex Ref K900292
510(k) 510(k)Snap Mycobacteria Avium Complex Ref K900202
510(k) 510(k)
Frequently asked questions
How many devices does Syngene, Inc. have in the registry?
The registry currently lists 2 devices for Syngene, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Syngene, Inc.'s devices?
Among its 2 most recently registered devices, Syngene, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Syngene, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Syngene, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Syngene, Inc. in the registry?
The most recently registered devices listed for Syngene, Inc. include SNAP M. TUBERCULOSIS COMPLEX and SNAP MYCOBACTERIA AVIUM COMPLEX.