Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Transasia Bio-MedicalsLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Diamedix with 68 510(k) clearances and 7 device recalls. The most recent is a device recall dated Jan 5, 2018: Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jan 5, 2018 | Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540Class III · Contains a gel-like contaminant that may affect product performance. | Device recalls |
| Jan 5, 2018 | Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640Class III · Contains a gel-like contaminant that may affect product performance. | Device recalls |
| Mar 26, 2015 | Diamedix Is-CMV IgG Test KitClass II · Product contained an incorrect substrate. | Device recalls |
| Oct 20, 2014 | Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative dClass II · A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. | Device recalls |
| Oct 20, 2014 | Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative Class II · A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. | Device recalls |
| Oct 20, 2014 | Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detClass II · A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. | Device recalls |
| Aug 6, 2012 | The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the deClass II · Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification | Device recalls |
| Jan 21, 2011 | MAGO 4SK093101 · LFX | 510(k) clearances |
| Jul 9, 2002 | DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEMK021394 · DHR | 510(k) clearances |
| Jan 8, 2002 | DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREENK013956 · MSV | 510(k) clearances |
| Dec 21, 2001 | DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEMK013628 · MSV | 510(k) clearances |
| Oct 26, 2001 | DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEMK012449 · MID | 510(k) clearances |
| Oct 26, 2001 | DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEMK012450 · MID | 510(k) clearances |
| Sep 28, 2001 | DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEMK012797 · MST | 510(k) clearances |
| Sep 28, 2001 | DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEMK012795 · MST | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
