Product code GRA
- Device name
- Antiserum, Fluorescent, Mumps Virus
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3380
- 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#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G5229032011 | Mumps IgG IFA Slide Only Kit | Hemagen Diagnostics, Inc. | 2023-10-05 |
| G5229032001 | Mumps IgG IFA 96 Test | Hemagen Diagnostics, Inc. | 2023-10-05 |
| 04053252364068 | Light Diagnostics ™ Mumps Control Slides | EMD Millipore Corporation | 2022-12-01 |
| 04053252282713 | Light Diagnostics ™ Mumps Monoclonal Antibody | EMD Millipore Corporation | 2022-11-30 |
| 04061839704138 | Light Diagnostics ™ Mumps Control Slide | EMD Millipore Corporation | 2022-11-30 |
| 04053252329746 | Light Diagnostics™ Mumps IFA Kit | EMD Millipore Corporation | 2022-11-28 |
| 04049016057499 | Anti-Mumps virus IFA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016057482 | Anti-Mumps virus IFA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016057475 | Anti-Mumps virus IFA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016057468 | Anti-Mumps virus IFA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016057505 | Anti-Mumps virus IFA (IgM) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016057512 | Anti-Mumps virus IFA (IgM) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016057529 | Anti-Mumps virus IFA (IgM) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016057536 | Anti-Mumps virus IFA (IgM) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016079514 | Anti-Mumps virus IFA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 00813545026035 | Mumps IgG 120 Test Kit | SCIMEDX CORPORATION | 2016-09-21 |
| 00813545026059 | Mumps 10 Well; 10 pk | SCIMEDX CORPORATION | 2016-09-21 |
| B110MUN80100 | Mumps Negative Control | Bion Enterprises, Ltd. | 2016-09-12 |
| B110MUM80300 | Mumps IgM Control | Bion Enterprises, Ltd. | 2016-09-12 |
| B110MUG80200 | Mumps IgG Control | Bion Enterprises, Ltd. | 2016-09-12 |
| B110MUG600 | Mumps IgG Test System, 60 Tests | Bion Enterprises, Ltd. | 2016-09-12 |
| B110MUG1200 | Mumps IgG Test System, 120 Tests | Bion Enterprises, Ltd. | 2016-09-12 |
| B110MU80120 | Mumps Virus Antigen Substrate, 12 wells, For IFA Test System | Bion Enterprises, Ltd. | 2016-09-12 |
| B110MU80060 | Mumps Virus Antigen Substrate, 6 wells, For IFA Test System | Bion Enterprises, Ltd. | 2016-09-12 |