Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
Microbiology · 21 CFR 866.3375
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
4 recall events for this product code
- Calbiotech IncTerminatedMar 5, 2010
EBV VCA IgG ELISA 96 Well Kit, Catalog Number: EV010G
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 related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations.
Z-0993-2010 · View FDA record ↗ - Calbiotech IncTerminatedMar 5, 2010
Mycoplasma IgG ELISA 96 Well Kit, Catalog Number: MP020G,
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 related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations.
Z-0997-2010 · View FDA record ↗ - Calbiotech IncTerminatedMar 5, 2010
Mycoplasma IgM ELISA 96 Well Kit, Catalog Number: MP021M
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 related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations.
Z-0998-2010 · View FDA record ↗ - Meridian Bioscience IncTerminatedUnknown
The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneum
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 would be made as to the cause of patient symptoms. The appropriate treatment may not be administered, and symptoms may progress. Additional evaluations will be completed and documented within the associated Health Hazard Evaluation.
Z-1299-2021 · View FDA record ↗
Registered firms
18 firms currently registered for this product code
Genbio
San Diego, CA, US
Gold Standard Diagnostics Frankfurt Gmbh
Dietzenbach Hesse, DE
Savyon Diagnostics Ltd.
ASHDOD Southern, IL
Trinity Biotech Usa
Jamestown, NY, US
Drg International, Inc.
Springfield, NJ, US
Zeus Scientific Llc
BRANCHBURG, NJ, US
Euroimmun Us Inc.
Mountain Lakes, NJ, US
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Remel Europe Ltd
DARTFORD, KENT, GB
Euroimmun Medizinische Labordiagnostika Ag
Dassow Mecklenburg-Western Pomerania, DE
Meridian Bioscience, Inc.
Cincinnati, OH, US
Remel, Inc.
LENEXA, KS, US
Drg Instruments Gmbh
MARBURG Hesse, DE
Euroimmun Medizinische Labordiagnostika Ag
Luebeck Schleswig-Holstein, DE
510(k) clearances
13 clearances for this product code
- Zeus Scientific, Inc.Jan 11, 1999
K984153 · THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.
- Zeus Scientific, Inc.Aug 20, 1997
K971503 · MYCOPLASMA IGM ELISA TEST SYSTEM
- Immunoprobe, Inc.Jul 14, 1997
K971393 · MYCOPLASMA IGG ELISA TEST SYSTEM
- Zeus Scientific, Inc.Jun 16, 1997
K970150 · MYCOPLASMA IGG ELISA TEST SYSTEM
- GenbioMay 5, 1997
K963054 · IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)
- GenbioMay 2, 1997
K963055 · IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120
- Meridian Diagnostics, Inc.Sep 20, 1994
K934550 · IMMUNOCARD MYCOPLASMA
- Shared Systems, Inc.Aug 20, 1992
K920212 · MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM