Viral Antigens, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Viral Antigens, Inc.” (first 1990, latest 1997), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 103 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 2 | 2 |
| GQW | Antigen, Cf, (Including Cf Control), Varicella-Zoster | 2 | 2 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 1 | 1 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | 1 | 1 |
Review panels
- Microbiology (6)
Most recent Viral Antigens, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971101 | HSV-2 ANTIGEN CONTROL SLIDES | GQN | 1997-07-01 | 97 |
| K964874 | HSV-1 ANTIGEN CONTROL SLIDES | GQN | 1997-07-01 | 208 |
| K964875 | CMV ANTIGEN CONTROL SLIDES | GQH | 1997-03-18 | 103 |
| K964872 | VZV ANTIGEN CONTROL SLIDES | GQW | 1997-03-18 | 103 |
| K964870 | RSV ANTIGEN CONTROL SLIDES | GQG | 1997-03-18 | 103 |
| K903882 | VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG | GQW | 1990-12-04 | 104 |
Recalls
openFDA lists no recalls under a recalling firm named Viral Antigens, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Viral Response System, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Viral Antigens, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Viral Antigens, Inc.” (first 1990, latest 1997), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Viral Antigens, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Viral Antigens, Inc. is 103 days.
Which FDA product codes appear under Viral Antigens, Inc.?
The most frequent FDA product codes under this applicant name are GQN (Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2, 2); GQW (Antigen, Cf, (Including Cf Control), Varicella-Zoster, 2); GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus, 1).
Next steps
- See all 6 Viral Antigens, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GQN, Viral Antigens, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.