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Sign in to claim this brandDiamedix Corp.
US
Last updated May 23, 2026
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Catalogue (116)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ez Complement C2 | K892125 | FDA 510(k) | Class II | Active |
| Is Ebv-Ebna-1 Igg Elisa Test System | K981829 | FDA 510(k) | Class I | Active |
| Diamedix Is-Cmv Igg Test System | K981163 | FDA 510(k) | Class II | Active |
| T-Uptake Microassay | K885034 | FDA 510(k) | Class II | Active |
| Ic Microassay | K864312 | FDA 510(k) | Class II | Active |
| Anti-Rnp Microassay | K901073 | FDA 510(k) | Class II | Active |
| Anti-Sci-70 Microassay | K902915 | FDA 510(k) | Class II | Active |
| Diamedix Is-Anti-Cardiolipin Iga Test System | K012450 | FDA 510(k) | Class II | Active |
| Rubella Igm Microassay | K883778 | FDA 510(k) | Class II | Active |
| Diamedix Is-Anti-Cardiolipin Igg/Igm Test System | K012449 | FDA 510(k) | Class II | Active |
| Is-Anti-Sm/Rnp (720-270) | K970238 | FDA 510(k) | Class II | Active |
| Is-Anti-Ssa Test System | K970218 | FDA 510(k) | Class II | Active |
| Is-Anti-Jo-1 Test System | K970228 | FDA 510(k) | Class II | Active |
| Diamedix Is-Hsv 1&2 Igm Test System | K002262 | FDA 510(k) | Class II | Active |
| Rubella Microassay | K864602 | FDA 510(k) | Class II | Active |
| Lyme Igm Microassay | K900572 | FDA 510(k) | Class II | Active |
| Lyme Disease Microassay | K890843 | FDA 510(k) | Class II | Active |
| Amebiasis Microassay | K863811 | FDA 510(k) | Class II | Active |
| Diamedix Is-Anti-B2 Glycoprotein I Igg/Igm Test System | K013628 | FDA 510(k) | Class II | Active |
| Anti-Jo-1 Microassay | K911679 | FDA 510(k) | Class II | Active |
| Thyroxine Microassay | K884260 | FDA 510(k) | Class II | Active |
| Ez Complement Reagents, 78n2212 | K870351 | FDA 510(k) | Class I | Active |
| Anti-Dna Microassay | K912020 | FDA 510(k) | Class II | Active |
| Is-Toxoplasma Igg Test System | K981498 | FDA 510(k) | Class II | Active |
| Diamedix Is-Anti-Cardiolipin Screen Test System | K012053 | FDA 510(k) | Class II | Active |
| Is-Anti-Ssb Test System (720-260) | K970237 | FDA 510(k) | Class II | Active |
| Is Ebv-Ea-D Igg Elisa Test System | K981831 | FDA 510(k) | Class I | Active |
| Is-Anti-Scl-70 Test System (720-280) | K970239 | FDA 510(k) | Class II | Active |
| Diamedix Is-Cmv Igm Capture Test System | K001767 | FDA 510(k) | Class II | Active |
| Diamedix Is-Ana Elisa Screen Test System | K993294 | FDA 510(k) | Class II | Active |
| Lyme Disease Microassay | K910899 | FDA 510(k) | Class II | Active |
| Mago 4s | K093101 | FDA 510(k) | Class II | Active |
| Is-Rubella Igg Test System | K981729 | FDA 510(k) | Class II | Active |
| Diamedix Is-Hsv 1 & 2 Igg Test System | K981306 | FDA 510(k) | Class II | Active |
| Pdq Amebiasis | K862473 | FDA 510(k) | Class II | Active |
| Ebv-Vca Igg Elisa Test System | K981812 | FDA 510(k) | Class I | Active |
| Is-Dsdna Test System | K974694 | FDA 510(k) | Class II | Active |
| Serum Hcg Microassay | K884430 | FDA 510(k) | Class II | Active |
| Anti-Dnp Microassay | K872560 | FDA 510(k) | Class II | Active |
| Diamedix Is-Anti-Dsdna Test System | K994424 | FDA 510(k) | Class II | Active |
| Is-Vzu Igg Test System | K981867 | FDA 510(k) | Class II | Active |
| Herpes 1 And 2 Microassays | K871420 | FDA 510(k) | Class II | Active |
| Diamedix Is-Rubella Igm Capture Test System | K001875 | FDA 510(k) | Class II | Active |
| Cmv Igm Microassay | K871832 | FDA 510(k) | Class II | Active |
| Tsh Microassay | K890579 | FDA 510(k) | Class II | Active |
| Lyme Igm Microassay | K911330 | FDA 510(k) | Class II | Active |
| Mago Automated Eia Processor | K973177 | FDA 510(k) | Class I | Active |
| Anti-Sm Microassay | K894894 | FDA 510(k) | Class II | Active |
| Measles Igg Microassay | K903961 | FDA 510(k) | Class I | Active |
| Toxoplasma Igg Microassay | K863813 | FDA 510(k) | Class II | Active |
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FDA Recalls (14)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 5, 2018 | Z-2574-2018 | — | terminated | Contains a gel-like contaminant that may affect product performance. |
| Jan 5, 2018 | Z-2573-2018 | — | terminated | Contains a gel-like contaminant that may affect product performance. |
| Mar 26, 2015 | Z-1689-2016 | — | terminated | Product contained an incorrect substrate. |
| Oct 20, 2014 | Z-1685-2016 | — | terminated | A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. |
| Oct 20, 2014 | Z-1686-2016 | — | terminated | A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. |
| Oct 20, 2014 | Z-1687-2016 | — | terminated | A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. |
| Aug 6, 2012 | Z-0445-2013 | — | terminated | Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification. |
| Jan 16, 2012 | Z-1520-2012 | — | terminated | On 01/16/20112 Diamedix initiated a recall of IS-HSV 1&2 IgM Test Kit, Catalog # 720-350, Lot 60701, Exp. June 30, 2012. The Positive Control for this lot is Out of Specification. |
| Jun 8, 2011 | Z-1620-2012 | — | terminated | On 06/08/2011 Diamedix Corporation initiated a recall of Is-ENA-6 Screen Test Kit, Catalog # 720-320 Master Lot S0000, Exp. Date May 31, 2012. The labeling on the kit box has an expiration date of 2012-05-31 while the components have an expiration date of 2012-04-30 for an incorrect expiration date. |
| Oct 10, 2008 | Z-0607-2009 | — | terminated | Possible false-negative test results: The Sample A Diluent Lot # 50768 assigned to Is-Measles IgG Lot #'s 41108 and 41108B has higher conductivity than normal, which can sporadically interfere with the MAGO Plus/Aptus sensing of and picking up of samples. As a result, if the sample is not picked up/processed, it could lead to the possibility of obtaining false negative results in some cases. |
| Mar 21, 2008 | Z-1684-2008 | — | terminated | Standards and controls in the Is-anti-Gliadin IgG Test Kits are exhibiting low activity. A drop in the O.D.s the Positive Control could potentially recover low out of range (which would invalidate the test), or false positive test results could be obtained. |
| Dec 23, 2004 | Z-0541-05 | — | terminated | The kits belonging to lot #s 30804/30804Z and 91803Z may lose activity, after one or two usages, causing the OD values for the Cut-Off Calibrator and/or Positive Control to be recovered below their specified ranges. |
| Dec 9, 2003 | Z-0513-04 | — | terminated | The test kit may have the potential to give erroneous results in that it may give higher frequency of equivocal/low positive results. |
| Sep 11, 2003 | Z-0325-05 | — | terminated | Several customers complained that either the negative control index value exceeded the upper control limit or there was very low activity of the cut off calibrator causing patient sample test runs to be called invalid. |