ClearanceBrief
Company ยท US

Diamedix Corp.

FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2011. Name variants (Inc, Corp, punctuation) are merged.

68510(k) clearances (0 in 12 months)
14recalls (0 in 12 months)
14recalls that name a 510(k)

Product codes

CodeDeviceRecords
LLLExtractable Antinuclear Antibody, Antigen And Control12
LFXEnzyme Linked Immunoabsorbent Assay, Rubella5
GNPAntiserum, Cf, Epstein-Barr Virus4
LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii4
LSRReagent, Borrelia Serological Reagent4
DHRSystem, Test, Rheumatoid Factor3
LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific3
LJBEnzyme Linked Immunoabsorbent Assay, Rubeola Igg3
LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control3
MIDSystem, Test, Anticardiolipin Immunological3
MSTAntibodies, Gliadin3
CZWComplement C3, Antigen, Antiserum, Control2
DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control2
KHWAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.2
LFYEnzyme Linked Immunoabsorbent Assay, Varicella-Zoster2
LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus2
LIPEnzyme Linked Immunoabsorption Assay, Treponema Pallidum2
LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls2
LJYEnzyme Linked Immunoabsorbent Assay, Mumps Virus2
LSEEpstein-Barr Virus, Other2

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jan 21, 2011K093101MAGO 4S
Diamedix Corp.
LFX
Jul 9, 2002K021394DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM
Diamedix Corp.
DHR
Jan 8, 2002K013956DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
Diamedix Corp.
MSV
Dec 21, 2001K013628DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM
Diamedix Corp.
MSV
Oct 26, 2001K012450DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM
Diamedix Corp.
MID
Oct 26, 2001K012449DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM
Diamedix Corp.
MID
Sep 28, 2001K012797DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
Diamedix Corp.
MST
Sep 28, 2001K012795DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
Diamedix Corp.
MST
Aug 20, 2001K012053DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM
Diamedix Corp.
MID
Nov 28, 2000K002262DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
Diamedix Corp.
LGC
Aug 21, 2000K001875DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM
Diamedix Corp.
LFX
Aug 7, 2000K001767DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM
Diamedix Corp.
LJO
Jul 7, 2000K001707DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM
Diamedix Corp.
LGD
Feb 18, 2000K994424DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM
Diamedix Corp.
LRM
Oct 25, 1999K993294DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM
Diamedix Corp.
LKJ
Mar 4, 1999K981812EBV-VCA IGG ELISA TEST SYSTEM
Diamedix Corp.
LSE
Feb 16, 1999K981831IS EBV-EA-D IGG ELISA TEST SYSTEM
Diamedix Corp.
GNP
Feb 16, 1999K981829IS EBV-EBNA-1 IGG ELISA TEST SYSTEM
Diamedix Corp.
GNP
Jan 28, 1999K981729IS-RUBELLA IGG TEST SYSTEM
Diamedix Corp.
LFX
Sep 29, 1998K981306DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM
Diamedix Corp.
LGC
Sep 28, 1998K981867IS-VZU IGG TEST SYSTEM
Diamedix Corp.
LFY
Sep 21, 1998K981163DIAMEDIX IS-CMV IGG TEST SYSTEM
Diamedix Corp.
LFZ
Aug 21, 1998K981498IS-TOXOPLASMA IGG TEST SYSTEM
Diamedix Corp.
LGD
Apr 23, 1998K980759DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM
Diamedix Corp.
LLL
Mar 6, 1998K974889DIAMEDIX IS-RF TEST SYSTEM
Diamedix Corp.
DHR
Mar 3, 1998K974694IS-DSDNA TEST SYSTEM
Diamedix Corp.
LRM
Jan 28, 1998K974552DIAMEDIX IS-MEASLES IGG TEST SYSTEM
Diamedix Corp.
LJB
Oct 9, 1997K973177MAGO AUTOMATED EIA PROCESSOR
Diamedix Corp.
JJF
Apr 8, 1997K970239IS-ANTI-SCL-70 TEST SYSTEM (720-280)
Diamedix Corp.
LLL
Apr 8, 1997K970238IS-ANTI-SM/RNP (720-270)
Diamedix Corp.
LLL
Apr 8, 1997K970237IS-ANTI-SSB TEST SYSTEM (720-260)
Diamedix Corp.
LLL
Apr 8, 1997K970228IS-ANTI-JO-1 TEST SYSTEM
Diamedix Corp.
LLL
Apr 8, 1997K970220IS-ANTI-SM TEST SYSTEM
Diamedix Corp.
LLL
Apr 8, 1997K970218IS-ANTI-SSA TEST SYSTEM
Diamedix Corp.
LLL
Sep 23, 1991K912020ANTI-DNA MICROASSAY
Diamedix Corp.
LRM
Sep 23, 1991K911679ANTI-JO-1 MICROASSAY
Diamedix Corp.
LLL
Jun 10, 1991K911330LYME IGM MICROASSAY
Diamedix Corp.
LSR
Jun 10, 1991K910899LYME DISEASE MICROASSAY
Diamedix Corp.
LSR
Dec 28, 1990K903961MEASLES IGG MICROASSAY
Diamedix Corp.
LJB
Sep 6, 1990K902915ANTI-SCI-70 MICROASSAY
Diamedix Corp.
LJM
May 2, 1990K900572LYME IGM MICROASSAY
Diamedix Corp.
LSR
Mar 19, 1990K901073ANTI-RNP MICROASSAY
Diamedix Corp.
LLL
Feb 2, 1990K900241ANTI-SSA MICROASSAY AND ANTI-SSB MICROASSAY
Diamedix Corp.
LLL
Aug 24, 1989K894894ANTI-SM MICROASSAY
Diamedix Corp.
LJM
Jul 25, 1989K890843LYME DISEASE MICROASSAY
Diamedix Corp.
LSR
May 15, 1989K890642VZV MICROASSAY
Diamedix Corp.
LFY
Apr 14, 1989K892129EZ COMPLEMENT C4
Diamedix Corp.
DBI
Apr 14, 1989K892127EZ COMPLEMENT C3
Diamedix Corp.
CZW
Apr 14, 1989K892125EZ COMPLEMENT C2
Diamedix Corp.
CZW
Apr 14, 1989K891904EZ COMPLEMENT C1
Diamedix Corp.
DAC

Newest 50 of 68.

Latest recalls

DateFirm and productCodeLinked 510(k)
Jan 5, 2018Diamedix Corporation
Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
Terminated		 GNPK981831
Jan 5, 2018Diamedix Corporation
Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540
Terminated		 LJYK991274
Mar 26, 2015Diamedix Corporation
Diamedix Is-CMV IgG Test Kit
Terminated		 LFZK981163
Oct 20, 2014Diamedix Corporation
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 detection of Mumps IgG antibodies as an aid in the diagnosis o
Terminated		 GNPK981831
Oct 20, 2014Diamedix Corporation
Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of
Terminated		 LSEK981812
Oct 20, 2014Diamedix Corporation
Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of M
Terminated		 LJYK991274
Aug 6, 2012Diamedix Corporation
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 detection and semi-quantitation of antibodies against the Sm ant
Terminated		 LLLK970220
May 21, 2012Diamedix Corporation
Product is labeled in part: "***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay Test Kit***Catalog No: 720-230***Exp. Date: 2012-05-31***Contains Sufficient for 96 Tests***C - Corrosive Harmf
Terminated		 LLLK980759
May 10, 2012Diamedix Corporation
Product is labeled in part: "***is immunosimplicity***HSV 1&2 IgM***Enzyme Immunoassay Test Kit***For the Detection of HSV 1&2 IgM antibodies***Catalog No: 720-350***Exp. Date:***Contains Sufficient
Terminated		 LGCK002262
Jan 7, 2009Diamedix Corporation
Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the semi-quantitation of human IgG antibodies to measles virus in human serum by indirect immunoassay to aid in the assess
Terminated		 LJBK974552
Sep 16, 2008Diamedix Corporation
Is-anti-Gliadin IgG Enzyme Immunoassay Test Kit packaged in cardboard boxes with individual components secured within a foam insert. Catalog Number # 720-800. - Laboratory In-Vitro Diagnostic Assay in
Terminated		 MSTK012795
Feb 15, 2005Diamedix Corporation
The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert.
Terminated		 LHLK970149
Dec 17, 2004Diamedix Corporation
The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for the qualitative detection of Treponema pallidum IgG antibodies in human serum or plasma. The reagents can be u
Terminated		 LIPK001552
Jul 20, 2004Diamedix Corporation
Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test, For in Vitro Diagnostic Use Lot 71303 Exp. Jun 04 Diamedix, A subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 3
Terminated		 LIPK001552
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