Product code LJY
- Device name
- Enzyme Linked Immunoabsorbent Assay, 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#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K991274 | MUMPS IGG ELISA TEST SYSTEM | Columbia Bioscience, Inc. | 1999-09-03 |
| K980059 | SERAQUEST MUMPS IGG | Quest Intl., Inc. | 1998-04-23 |
| K971857 | MUMPS IGG ELISA TESTY | Gull Laboratories, Inc. | 1997-11-04 |
| K961204 | MUMPS IGG TEST | Zeus Scientific, Inc. | 1996-07-18 |
| K925209 | MUMPS STAT | Biowhittaker Molecular Applications, Inc. | 1994-10-14 |
| K923903 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA | Biomerieux Vitek, Inc. | 1993-08-09 |
| K897006 | PHARMACIA MUMPS IGG ELISA | Pharmacia Eni Diagnostics, Inc. | 1990-07-26 |
| K830045 | MUMPSELISA TEST KIT | M.A. Bioproducts | 1983-05-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| ENTIMUMG03400 | NovaLisa Mumps Virus IgG | Gold Standard Diagnostics Frankfurt GmbH | 2024-08-26 |
| ENTIMUMG0340 | NovaLisa Mumps Virus IgG | Gold Standard Diagnostics Frankfurt GmbH | 2024-08-26 |
| 00840239038470 | Mumps IgM ELISA | DRG International Inc | 2024-08-20 |
| 04048474038477 | Mumps IgM ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2024-08-20 |
| 08033891322458 | CHORUS MUMPS IgG | DIESSE DIAGNOSTICA SENESE SPA | 2024-01-22 |
| 00847865010771 | Bio-Rad Laboratories | Bio-RAD Laboratories, Inc. | 2023-01-04 |
| 00894175000060 | AccuDiag ™ | Diagnostic Automation, Inc. | 2021-08-10 |
| B3507205400 | Gold Standard Diagnostics Is-Mumps IgG ELISA Test Kit | Gold Standard Diagnostics Corporation | 2020-07-27 |
| 05391516743600 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-10-25 |
| 03573026064525 | VIDAS® Mumps IgG | BIOMERIEUX SA | 2019-09-16 |
| 04048474038460 | Mumps Virus IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2019-06-05 |
| 00404847438468 | Mumps Virus IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2019-06-05 |
| 00840239038463 | Mumps Virus IgG ELISA | DRG International Inc | 2019-03-20 |
| 05391516747110 | Trinity Biotech | CLARK LABORATORIES, INC. | 2017-05-07 |
| 04049016028017 | Anti-Mumps Virus ELISA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016028024 | Anti-Mumps Virus ELISA (IgM) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016083283 | Anti-Mumps Virus AT ELISA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016103646 | Anti-Mumps Virus ELISA (G5) (IgM) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 05391516743617 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-23 |
| 05391516743624 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-23 |
| 00847865002189 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865010979 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000734 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865002332 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865002264 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000765 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000758 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000741 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000727 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00850487007081 | ReQuest | QUEST INTERNATIONAL, INC. | 2016-08-31 |