Product code LJZ
- Device name
- Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3375
- 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 |
|---|---|---|---|
| K984153 | THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM. | Zeus Scientific, Inc. | 1999-01-11 |
| K971503 | MYCOPLASMA IGM ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1997-08-20 |
| K971393 | MYCOPLASMA IGG ELISA TEST SYSTEM | Immunoprobe, Inc. | 1997-07-14 |
| K970150 | MYCOPLASMA IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1997-06-16 |
| K963054 | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) | Genbio | 1997-05-05 |
| K963055 | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 | Genbio | 1997-05-02 |
| K934550 | IMMUNOCARD MYCOPLASMA | Meridian Diagnostics, Inc. | 1994-09-20 |
| K920212 | MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM | Shared Systems, Inc. | 1992-08-20 |
| K921556 | MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM | Medical Diagnostic Technologies, Inc. | 1992-06-29 |
| K904501 | MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM | Medical Diagnostic Technologies, Inc. | 1991-02-26 |
| K895276 | DIATECH IGM-MP TEST | Diatech Diagnostica , Ltd. | 1989-12-18 |
| K882596 | MP TEST | Diatech Diagnostica , Ltd. | 1989-06-21 |
| K823804 | MYCOPLASMELISA TEST KIT | M.A. Bioproducts | 1983-05-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00613745000145 | ImmunoFLOW Negative Control Mycoplasma IgM | GenBio | 2026-04-19 |
| 00613745000091 | ImmunoFLOW Mycoplasma IgM Positive Control | GenBio | 2026-04-19 |
| 00613745000060 | IMMUNOFLOW™ Mycoplasma pneumoniae IgM Test | GenBio | 2025-08-31 |
| 00613745031200 | ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgG) TEST | GenBio | 2025-08-29 |
| 00613745031309 | ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgM) TEST | GenBio | 2025-08-29 |
| ENTIMYCG03500 | NovaLisa Mycoplasma pneumoniae IgG | Gold Standard Diagnostics Frankfurt GmbH | 2024-08-26 |
| 04048474045598 | Mycoplasma hominis IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-31 |
| 04048474046236 | Ureaplasma urealyticum IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-31 |
| 04048474034998 | Mycoplasma pneumoniae IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 00840239046239 | Ureaplasma urealyticum IgG ELISA | DRG International Inc | 2023-08-25 |
| 00840239034991 | Mycoplasma pneumoniae IgG ELISA | DRG International Inc | 2023-08-24 |
| 00894175000749 | AccuDiag ™ | Diagnostic Automation, Inc. | 2023-06-14 |
| 00404847434996 | Mycoplasma pneumoniae IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 00404847445596 | Mycoplasma hominis IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 00404847446234 | Ureaplasma urealyticum IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 00840733101762 | ImmunoCard Mycoplasma | MERIDIAN BIOSCIENCE, INC. | 2020-08-11 |
| 05391516743945 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-11-06 |
| 04049016027645 | Anti-Mycoplasma pneumoniae ELISA (IgA) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016027652 | Anti-Mycoplasma pneumoniae ELISA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016027669 | Anti-Mycoplasma pneumoniae ELISA (IgM) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 05391516743358 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-21 |
| 00817273020419 | Diamedix | DIAMEDIX CORPORATION | 2016-09-20 |