Panels › Microbiology › Product code LJZ · Class 1
Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
Regulation 866.3375
0510(k)s in 12 months (13 all time)
0recalls in 12 months (4 all time)
1recalls that name a 510(k)
Top companies in LJZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Calbiotech Inc | 0 | 3 |
| Zeus Scientific, Inc. | 3 | 0 |
| Diatech Diagnostica , Ltd. | 2 | 0 |
| Genbio | 2 | 0 |
| Medical Diagnostic Technologies, Inc. | 2 | 0 |
| Immunoprobe, Inc. | 1 | 0 |
| M.A. Bioproducts | 1 | 0 |
| Meridian Bioscience Inc | 0 | 1 |
| Meridian Diagnostics, Inc. | 1 | 0 |
| Shared Systems, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2021 | Meridian Bioscience Inc 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 pneumoniae infection. Terminated |
LJZ | K934550 |
| Mar 5, 2010 | Calbiotech Inc Mycoplasma IgM ELISA 96 Well Kit, Catalog Number: MP021M
The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. Terminated |
LJZ | None listed |
| Mar 5, 2010 | Calbiotech Inc Mycoplasma IgG ELISA 96 Well Kit, Catalog Number: MP020G,
The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. Terminated |
LJZ | None listed |
| Mar 5, 2010 | Calbiotech Inc EBV VCA IgG ELISA 96 Well Kit, Catalog Number: EV010G
The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. Terminated |
LJZ | None listed |
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