Panels › Microbiology › Product code LGD · Class 2
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Regulation 866.3780
0510(k)s in 12 months (106 all time)
0recalls in 12 months (7 all time)
4recalls that name a 510(k)
Top companies in LGD
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2025 | Bio-Rad Laboratories, Inc. Platelia Toxo IgM Catalog Number 26211
UDI Code: 03610520005552
The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplas Open, Classified |
LGD | K090847 |
| Sep 22, 2021 | bioMerieux, Inc. VIDAS TOXO IgG Avidity (TXGA), REF 30222-01 Open, Classified |
LGD | None listed |
| Mar 23, 2018 | BioMerieux SA VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity in human serum or plasma (lithium heparin, sodium Terminated |
LGD | K101946 |
| Mar 11, 2011 | BioCheck Inc Toxoplasma IgG ELISA kit ;
Toxoplasma IgM ELISA kit
BioCheck, Foster City, CA 9440.
Quantitative determination of AFP concentration in human serum. Terminated |
LGD | None listed |
| Mar 5, 2010 | Calbiotech Inc Toxoplasma IgM ELISA 96 Well Kit, Catalog Number: TX055M
The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. Terminated |
LGD | None listed |
| Jul 11, 2007 | Abbott Laboratories AxSYM Toxo IgM Reagent Pack; list 04B25; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LGD | K954576 |
| Jul 11, 2007 | Abbott Laboratories AxSYM Toxo IgG Reagent Pack; list 03B22; 100 test pack; an in vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LGD | K954575 |
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