Panels › Immunology › Product code LOJ · Class 2
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Regulation 866.6010
0510(k)s in 12 months (17 all time)
0recalls in 12 months (7 all time)
3recalls that name a 510(k)
Top companies in LOJ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK AFP; Part Number: 025252
Assay, Tumor Marker Terminated |
LOJ | K023894 |
| May 9, 2016 | ORTHO-CLINICAL DIAGNOSTICS VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: th Terminated |
LOJ | K983031 |
| Mar 11, 2011 | BioCheck Inc AFP ELISA Kit;
AFP ELISA kit (Extended range);
BioCheck, Foster City, CA 94404
Quantitative determination of AFP concentration in human serum. Terminated |
LOJ | None listed |
| Sep 18, 2009 | Abbott Laboratories Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the AxSYM System; Abbott Laboratories, Abbott Park, IL 60064; List Number 3D50-05.
AxSYM AFP is a Microparticle Enzyme Imm Terminated |
LOJ | None listed |
| Jan 9, 2008 | Abbott Laboratories ARCHITECT i System Assay CD-ROM - WW (excluding USA accounts), Versions prior to Version 24.0; for use on the ARCHITECT i System; List Number (LN) 6E59,Abbott Laboratories, Diagnostics Division, Abbot Terminated |
LOJ | None listed |
| Aug 23, 2005 | Beckman Coulter Inc Access Immunoassay Systems Assay Protocol: Dil-AFP. Terminated |
LOJ | K981354 |
| Apr 16, 2003 | Abbott Laboratories HPD/ADD Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP (human), nonreactive for anti-HIV-1/HIV-2 and HCV and nonreactive for HBsAg, inbuffered calf serum at the following co Terminated |
LOJ | None listed |
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