Product code LJB
- Device name
- Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3520
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- The qualitative detection of measles specific IgG antibodies in serum or plasma.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974552 | DIAMEDIX IS-MEASLES IGG TEST SYSTEM | Diamedix Corp. | 1998-01-28 |
| K971620 | QUANTA LITE RUBEOLA (MEASLES) IGG | Inova Diagnostics, Inc. | 1997-07-22 |
| K922330 | BARTELS RUBEOLA IGG EIA | Baxter Diagnostics, Inc. | 1992-09-02 |
| K922335 | BARTELS RUBEOLA IGM EIA | Baxter Diagnostics, Inc. | 1992-09-02 |
| K910290 | VIRATEST-DIA(TM) MEASLES (RUBEOLA) | Virus Reference Laboratory, Inc. | 1992-03-18 |
| K904083 | RUBEOLA IGM ELISA TEST | Gull Laboratories, Inc. | 1991-01-03 |
| K903961 | MEASLES IGG MICROASSAY | Diamedix Corp. | 1990-12-28 |
| K904854 | RUBEOLA IGG ELISA TEST | Gull Laboratories, Inc. | 1990-12-04 |
| K891990 | RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 | Clinical Sciences, Inc. | 1989-06-15 |
| K873925 | VIRGO(TM) MEASLES IGG ELISA | Electro-Nucleonics Laboratories, Inc. | 1988-02-24 |
| K821762 | MEASELISA TEST KIT | M.A. Bioproducts | 1982-07-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04049016158547 | Anti-Measles Virus ELISA 2.0 (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2026-05-29 |
| 00850054026156 | QMedix™ | Diagnostic Automation, Inc. | 2025-06-05 |
| ENTIMEAG03300 | NovaLisa Measles Virus IgG | Gold Standard Diagnostics Frankfurt GmbH | 2024-08-26 |
| ENTIMEAG0330 | NovaLisa Measles Virus IgG | Gold Standard Diagnostics Frankfurt GmbH | 2024-08-26 |
| 08033891322434 | CHORUS MEASLES IgG | DIESSE DIAGNOSTICA SENESE SPA | 2024-01-22 |
| 04048474059670 | Measles Virus IgG Avidity ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-09-01 |
| 00840239059673 | Measles Virus IgG Avidity ELISA | DRG International Inc | 2023-08-26 |
| 00850049545396 | AccuDiag ™ | Diagnostic Automation, Inc. | 2023-06-14 |
| 00847865010764 | Bio-Rad Laboratories | Bio-RAD Laboratories, Inc. | 2023-01-22 |
| 00404847459678 | Measles Virus IgG Avidity ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| B3507205200 | Gold Standard Diagnostics Is-Measles IgG ELISA Test Kit | Gold Standard Diagnostics Corporation | 2020-05-20 |
| 05391516747127 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-10-25 |
| 05391516743631 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-10-25 |
| 03573026064532 | VIDAS® Measles IgG | BIOMERIEUX SA | 2019-08-30 |
| 04048474038446 | Measles Virus IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2019-06-05 |
| 00404847438444 | Measles Virus IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2019-06-05 |
| 00840239038449 | Measles Virus IgG ELISA | DRG International Inc | 2019-03-20 |
| 04049016027973 | Anti-Measles Virus ELISA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016083276 | Avidity: Anti-Measles Virus ELISA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 00847865000727 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000741 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865010979 | 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 |
| 00847865002189 | 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 |
| 00847865000734 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00850487007104 | ReQuest | QUEST INTERNATIONAL, INC. | 2016-08-31 |
| 00850487007111 | ReQuest | QUEST INTERNATIONAL, INC. | 2016-08-31 |