Product code GNS
- Device name
- Antisera, Hai, Influenza Virus A, B, C
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3330
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K780696 | GOAT ANTIINFLUENZA ANTISERA AUSSR | Northeast Biomedical Labs., Inc. | 1978-05-03 |
| K780697 | GOAT ANTI-INFLUENZA ANTISERA ATEXAS | Northeast Biomedical Labs., Inc. | 1978-05-03 |
| K780273 | INFLUENZA HI PRESERUM | Flow Laboratories, Inc. | 1978-02-28 |
| K780274 | INFLUENZA HI ANTISERUM | Flow Laboratories, Inc. | 1978-02-28 |
| K780276 | INFLUENZA HI ANTISERUM A/TEXAS | Flow Laboratories, Inc. | 1978-02-28 |
| K780277 | INFLUENZA HI PRESERUM A/TEXAS | Flow Laboratories, Inc. | 1978-02-28 |
| K780004 | GOAT ANTI-INFLUENZA ANTISERA | Northeast Biomedical Labs., Inc. | 1978-01-20 |
| K780005 | GOAT ANTI-INFLUENZA ANTISERA | Northeast Biomedical Labs., Inc. | 1978-01-20 |
| K780006 | GOAT ANTI-INFLUENZA ANTISERA | Northeast Biomedical Labs., Inc. | 1978-01-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 30014613330844 | D3 Fastpoint | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330851 | D3 Fastpoint | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330868 | D3 Fastpoint | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330875 | D3 Fastpoint | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330769 | D3 Fastpoint | DIAGNOSTIC HYBRIDS, INC. | 2018-07-22 |
| 30014613330776 | D3 Fastpoint | DIAGNOSTIC HYBRIDS, INC. | 2018-07-22 |
| 04049016096764 | Anti-Influenza A/B Virus Pool ELISA (IgM) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016028352 | Anti-Influenza B Virus ELISA (IgM) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016028345 | Anti-Influenza B Virus ELISA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016028338 | Anti-Influenza B Virus ELISA (IgA) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016028321 | Anti-Influenza A/B Virus Pool ELISA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016028307 | Anti-Influenza A Virus ELISA (IgM) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016028291 | Anti-Influenza A Virus ELISA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016028284 | Anti-Influenza A Virus ELISA (IgA) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 30014613330752 | D3 Fastpoint | DIAGNOSTIC HYBRIDS, INC. | 2016-09-15 |
| B110IBN21100 | Influenza B Negative Control | Bion Enterprises, Ltd. | 2016-09-12 |
| B110IBG21200 | Influenza B IgG Control | Bion Enterprises, Ltd. | 2016-09-12 |
| B110IB21120 | Influenza B Virus Antigen Substrate, 12 wells, For IFA Test System | Bion Enterprises, Ltd. | 2016-09-12 |
| B110IAN11100 | Influenza A Negative Control | Bion Enterprises, Ltd. | 2016-09-12 |
| B110IAG11200 | Influenza A IgG Control | Bion Enterprises, Ltd. | 2016-09-12 |
| B110IA11120 | Influenza A Virus Antigen Substrate, 12 wells, For IFA Test System | Bion Enterprises, Ltd. | 2016-09-12 |