Zymetx, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 4
What Zymetx, Inc. makes
Zymetx, Inc. manufactures diagnostic tests for respiratory viruses, including rapid detection kits for influenza types A and B, culture confirmation screens for influenza and parainfluenza viruses, and monoclonal antibody reagents labeled with FITC for viral identification.
The company’s products are regulated under FDA Class I and Class II classifications, with several devices listed via the 510(k) pathway. The portfolio is based in the United States.
Catalogue
- 510(k) 510(k)
- 510(k) 510(k)
- 510(k) 510(k)
- 510(k) 510(k)
Frequently asked questions
How many devices does Zymetx, Inc. have in the registry?
The registry currently lists 4 devices for Zymetx, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zymetx, Inc.'s devices?
Among its 4 most recently registered devices, Zymetx, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Zymetx, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Zymetx, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Zymetx, Inc. in the registry?
The most recently registered devices listed for Zymetx, Inc. include ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES, VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES, VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES and VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES.