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Diamedix Corp.

Last updated May 23, 2026

Information

Country: US
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Catalogue (116)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Diamedix	720-380	FDA UDI	Class II	Active
Diamedix	789-008	FDA UDI	Class I	Active
Diamedix	720-250	FDA UDI	Class II	Active
Diamedix	720-540	FDA UDI	Class I	Active
Diamedix	720-650	FDA UDI	Class I	Active
Diamedix	720-710	FDA UDI	Class II	Active
Diamedix	720-310	FDA UDI	Class II	Active
Diamedix	720-440	FDA UDI	Class II	Active
Diamedix	789-006	FDA UDI	Class I	Active
Diamedix	720-700	FDA UDI	Class II	Active
Diamedix	300-371A	FDA UDI	Class II	Active
Diamedix	720-630	FDA UDI	Class I	Active
Diamedix	720-520	FDA UDI	Class II	Active
Diamedix	251-035	FDA UDI	Class II	Active
Diamedix	720-350	FDA UDI	Class II	Active
Diamedix	720-270	FDA UDI	Class II	Active
Diamedix	789-009	FDA UDI	Class I	Active
Diamedix	300-312A	FDA UDI	Class II	Active
Diamedix	720-640	FDA UDI	Class I	Active
Diamedix	720-850	FDA UDI	Class I	Active
Diamedix	MAGO 4S	FDA UDI	Class I	Active
Diamedix	720-290	FDA UDI	Class II	Active
Diamedix	720-460	FDA UDI	Class II	Active
Diamedix	72-260	FDA UDI	Class II	Active
Diamedix	720-400	FDA UDI	Class II	Active
Diamedix	720-450	FDA UDI	Class II	Active
Diamedix	720-370	FDA UDI	Class II	Active
Diamedix	720-600	FDA UDI	Class I	Active
Diamedix	MAGO Plus	FDA UDI	Class I	Active
Diamedix	720-130	FDA UDI	Class II	Active
Diamedix	720-340	FDA UDI	Class II	Active
Diamedix	720-360	FDA UDI	Class II	Active
Diamedix	720-790	FDA UDI	Class II	Active
Diamedix	720-230	FDA UDI	Class II	Active
Diamedix	300-331A	FDA UDI	Class I	Active
Diamedix	720-420	FDA UDI	Class II	Active
Diamedix	720-300	FDA UDI	Class II	Active
Diamedix	789-001	FDA UDI	Class I	Active
Diamedix	720-330	FDA UDI	Class II	Active
Diamedix	720-480	FDA UDI	Class II	Active
Diamedix	720-830	FDA UDI	Class II	Active
Diamedix	720-280	FDA UDI	Class II	Active
Diamedix	720-240	FDA UDI	Class II	Active
Diamedix	720-320	FDA UDI	Class II	Active
Diamedix	720-620	FDA UDI	Class I	Active
Diamedix	720-430	FDA UDI	Class II	Active
Diamedix	250-030	FDA UDI	Class II	Active
Diamedix	720-610	FDA UDI	Class I	Active
Diamedix Is-Rheumatoid Factor Test System	K021394	FDA 510(k)	Class II	Active
Ez Complement C4	K892129	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.