Product code GQT
- Device name
- Antisera, Cf, Parainfluenza Virus 1-4
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3400
- 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 |
|---|---|---|---|
| K872695 | PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN | Sita, Inc. | 1987-09-18 |
| K872696 | PARAINFLUENZA-3-CF ANTIGEN AND CONTROL ANTIGEN | Sita, Inc. | 1987-09-18 |
| K872697 | PARAINFLUENZA-I-CF ANTIGEN AND CONTROL ANTIGEN | Sita, Inc. | 1987-09-18 |
| K780008 | GOAT ANTI-INFLUENZA ANTISERA | Northeast Biomedical Labs., Inc. | 1978-01-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04053252670114 | Light Diagnostics ™ Parainfluenza 4 Control Slides (5 Pack) | EMD Millipore Corporation | 2022-12-01 |
| 04053252325519 | Light Diagnostics ™ Parainfluenza 1, 2, 3 Control Slides | EMD Millipore Corporation | 2022-12-01 |
| 04061841171485 | Light Diagnostics ™ Para 4 Control Slide | EMD Millipore Corporation | 2022-11-30 |
| 04053252783258 | Light Diagnostics ™ Para-influenza 1, 2, 3 Control Slide | EMD Millipore Corporation | 2022-11-30 |
| 04053252739583 | Light Diagnostics ™ SimulFluor® Para 1, 2, 3/ Adeno Reagent | EMD Millipore Corporation | 2022-11-30 |
| 04053252730818 | Light Diagnostics ™ Parainfluenza 1 FITC-Labeled Monoclonal Antibody | EMD Millipore Corporation | 2022-11-30 |
| 04053252728365 | Light Diagnostics ™ Para 4 DFA Reagent | EMD Millipore Corporation | 2022-11-30 |
| 04053252471469 | Light Diagnostics ™ Parainfluenza Pan FITC-Labeled Monoclonal Antibodies | EMD Millipore Corporation | 2022-11-30 |
| 04053252403040 | Light Diagnostics ™ SimulFluor® Parainfluenza 1, 2/3 Reagent | EMD Millipore Corporation | 2022-11-30 |
| 04053252362224 | Light Diagnostics ™ Parainfluenza 2 FITC-Labeled Monoclonal Antibody | EMD Millipore Corporation | 2022-11-30 |
| 04053252280238 | Light Diagnostics ™ Parainfluenza 3 FITC-Labeled Monoclonal Antibody | EMD Millipore Corporation | 2022-11-30 |
| 04053252322273 | Light Diagnostics ™ Parainfluenza 2 Monoclonal Antibody | EMD Millipore Corporation | 2022-11-29 |
| 04053252513121 | Light Diagnostics™ SimulFluor® Para 1, 2, 3/ Adeno DFA Kit | EMD Millipore Corporation | 2022-11-29 |
| 04053252672743 | Light Diagnostics ™ Parainfluenza 1 Monoclonal Antibody | EMD Millipore Corporation | 2022-11-29 |
| 04053252728358 | Light Diagnostics™ SimulFluor® Parainfluenza 1, 2 /3 DFA Kit | EMD Millipore Corporation | 2022-11-29 |
| 04053252738081 | Light Diagnostics ™ Parainfluenza 2 Monoclonal Antibody | EMD Millipore Corporation | 2022-11-29 |
| 08436037124891 | Light Diagnostics™ Parainfluenza 1, 2, and 3 DFA Kit | EMD Millipore Corporation | 2022-11-28 |
| 04049016028369 | Anti-Parainfluenza Viruses Pool ELISA (IgA) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016028376 | Anti-Parainfluenza Viruses Pool ELISA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016028383 | Anti-Parainfluenza Viruses Pool ELISA (IgM) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |