Diagnon Corp.
United StatesFDA applicant, unverified
- Devices
- 6
What Diagnon Corp. makes
Diagnon Corp. manufactures diagnostic test kits and viral transport systems, including radiolabeled immunoassay kits for measuring folate (125I) and vitamin B12 (57Co), as well as an immunoperoxidase typing test for herpes and a combined vitamin B12/folate radioassay kit. The company also produces modified viral transport containers for specimen collection and handling.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the 510(k) clearance pathway. These products are listed in the US and comply with applicable medical device regulations.
Catalogue
Virtran Viral Transporter (Modified) Ref K860967
Regimes: 510(k) Registry: 510(k)Diagnon Folate 125I Ria Kit Ref K841302
Regimes: 510(k) Registry: 510(k)Diagnon B12 57CO Ria Kit Ref K832717
Regimes: 510(k) Registry: 510(k)Virtran Viral Tranporter Ref K851378
Regimes: 510(k) Registry: 510(k)Diagnon Herpes Immunoperoxidase Typing Test Ref K851635
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Diagnon Corp. have in the registry?
The registry currently lists 6 devices for Diagnon Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diagnon Corp.'s devices?
Among its 6 most recently registered devices, Diagnon Corp. has devices listed in FDA 510(k) (6 devices).
What risk classes do Diagnon Corp.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Diagnon Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Diagnon Corp. in the registry?
The most recently registered devices listed for Diagnon Corp. include VIRTRAN VIRAL TRANSPORTER (MODIFIED), DIAGNON FOLATE 125I RIA KIT, DIAGNON B12 57CO RIA KIT and VIRTRAN VIRAL TRANPORTER.