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Diamedix Corporation

7 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Product is labeled in part: "***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay Te recall (Z-1620-2012)Diamedix Corporation2012-05-21
Product is labeled in part: "***is immunosimplicity***HSV 1&2 IgM***Enzyme Immunoassay Tes recall (Z-1520-2012)Diamedix Corporation2012-05-10
Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the semi-quan recall (Z-0607-2009)Diamedix Corporation2009-01-07
Is-anti-Gliadin IgG Enzyme Immunoassay Test Kit packaged in cardboard boxes with individua recall (Z-1684-2008)Diamedix Corporation2008-09-16
The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual co recall (Z-0541-05)Diamedix Corporation2005-02-15
The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for recall (Z-0325-05)Diamedix Corporation2004-12-17
Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test, recall (Z-0513-04)Diamedix Corporation2004-07-20

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Every clearance here is in the API, with alerts when new ones post.