Home › Device types › LJZ
Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
FDA product code LJZ · Class 1 · Microbiology
25
Registered devices
0
Adverse events
4
Recalls
13
510(k) clearances
Devices with this code
ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgG) TEST — GenBioUreaplasma urealyticum IgG ELISA — DRG International IncSeroMP IgG — SAVYON DIAGNOSTICS LTDMycoplasma pneumoniae IgG ELISA — DRG International IncImmunoFLOW Mycoplasma IgM Positive Control — GenBioMycoplasma hominis IgG ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungDiamedix — DIAMEDIX CORPORATIONTrinity Biotech — CLARK LABORATORIES, INC.ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgM) TEST — GenBioAnti-Mycoplasma pneumoniae ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AGImmunoFLOW Negative Control Mycoplasma IgM — GenBioUreaplasma urealyticum IgG ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungUreaplasma urealyticum IgG ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungSeroMP IgM — SAVYON DIAGNOSTICS LTDAnti-Mycoplasma pneumoniae ELISA (IgM) — EUROIMMUN Medizinische Labordiagnostika AGMycoplasma hominis IgG ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungNovaLisa Mycoplasma pneumoniae IgG — Gold Standard Diagnostics Frankfurt GmbHAccuDiag ™ — Diagnostic Automation, Inc.SeroMP IgA — SAVYON DIAGNOSTICS LTDAnti-Mycoplasma pneumoniae ELISA (IgA) — EUROIMMUN Medizinische Labordiagnostika AGIMMUNOFLOW™ Mycoplasma pneumoniae IgM Test — GenBioMycoplasma pneumoniae IgG ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungTrinity Biotech — CLARK LABORATORIES, INC.Mycoplasma pneumoniae IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-02-08 | Meridian Bioscience Inc | Use of the kits after incorrect storage could lead to a potential false-negative or invalid result. In the event of a false-negative, the incorrect assumption w |
| 2008-08-27 | Calbiotech Inc | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard rel |
| 2008-08-27 | Calbiotech Inc | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard rel |
| 2008-08-27 | Calbiotech Inc | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard rel |
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