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Diamedix Corp.

Last updated May 23, 2026

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Country: US
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Catalogue (116)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
Diamedix Is-Ena-6 Screen Test System	K980759	FDA 510(k)	Class II	Active
Toxoplasma Igm Microassay	K870753	FDA 510(k)	Class II	Active
Diamedix Is-Anti-Gliadin Iga Test System	K012797	FDA 510(k)	Class II	Active
Anti-Dna Microassay	K863717	FDA 510(k)	Class II	Active
Rf Microassay	K871041	FDA 510(k)	Class II	Active
Diamedix Is-Anti-B2 Glycoprotein I Screen	K013956	FDA 510(k)	Class II	Active
Diamedix Is-Measles Igg Test System	K974552	FDA 510(k)	Class I	Active
Diamedix Is-Toxoplasma Igm Capture Test System	K001707	FDA 510(k)	Class II	Active
Cmv Microassay	K864420	FDA 510(k)	Class II	Active
Vzv Microassay	K890642	FDA 510(k)	Class II	Active
Anti-Ssa Microassay And Anti-Ssb Microassay	K900241	FDA 510(k)	Class II	Active
Ez Complement C3	K892127	FDA 510(k)	Class II	Active
Diamedix Is-Rf Test System	K974889	FDA 510(k)	Class II	Active
Ez Complement C1	K891904	FDA 510(k)	Class II	Active
Diamedix Is-Anti-Gliadin Igg Test System	K012795	FDA 510(k)	Class II	Active
Is-Anti-Sm Test System	K970220	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.