Viral Antigens, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Viral Antigens, Inc. makes
Viral Antigens, Inc. manufactures antigen control slides and antibody test kits for viral infections, including HSV-1, HSV-2, CMV, VZV, and RSV. The HSV-2, CMV, VZV, and RSV antigen control slides are designed for use in diagnostic testing to validate assay performance. The Varicella-Zoster Virus antibody test kit uses latex agglutination for detecting antibodies in patient samples.
The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I or Class II. These products are listed in the FDA’s 510(k) database, and the company is based in the United States.
Catalogue
Hsv-2 Antigen Control Slides Ref K971101
Regimes: 510(k) Registry: 510(k)Cmv Antigen Control Slides Ref K964875
Regimes: 510(k) Registry: 510(k)Vzv Antigen Control Slides Ref K964872
Regimes: 510(k) Registry: 510(k)Rsv Antigen Control Slides Ref K964870
Regimes: 510(k) Registry: 510(k)Hsv-1 Antigen Control Slides Ref K964874
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Viral Antigens, Inc. have in the registry?
The registry currently lists 6 devices for Viral Antigens, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Viral Antigens, Inc.'s devices?
Among its 6 most recently registered devices, Viral Antigens, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Viral Antigens, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Viral Antigens, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Viral Antigens, Inc. in the registry?
The most recently registered devices listed for Viral Antigens, Inc. include HSV-2 ANTIGEN CONTROL SLIDES, CMV ANTIGEN CONTROL SLIDES, VZV ANTIGEN CONTROL SLIDES and RSV ANTIGEN CONTROL SLIDES.