Diamedix Corp.
Miami, FL, US
Diamedix Corp. appears in FDA device records in Miami, FL. FDA records list 68 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 14 recalls for this company.
FDA records held for this company
510(k) clearance history
Showing 50 of 68FDA records hold 68 510(k) clearances for Diamedix Corp. between 1986 and 2011. The busiest year on record is 1989, with 10. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 4 |
| 1987 | 9 |
| 1988 | 2 |
| 1989 | 10 |
| 1990 | 5 |
| 1991 | 4 |
| 1997 | 7 |
| 1998 | 8 |
| 1999 | 5 |
| 2000 | 5 |
| 2001 | 6 |
| 2002 | 2 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K093101 | MAGO 4S | LFX | Substantially Equivalent | |
| K021394 | DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM | DHR | Substantially Equivalent | |
| K013956 | DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN | MSV | Substantially Equivalent | |
| K013628 | DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM | MSV | Substantially Equivalent | |
| K012450 | DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM | MID | Substantially Equivalent | |
| K012449 | DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM | MID | Substantially Equivalent | |
| K012797 | DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM | MST | Substantially Equivalent | |
| K012795 | DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM | MST | Substantially Equivalent | |
| K012053 | DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM | MID | Substantially Equivalent | |
| K002262 | DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM | LGC | Substantially Equivalent | |
| K001875 | DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM | LFX | Substantially Equivalent | |
| K001767 | DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM | LJO | Substantially Equivalent | |
| K001707 | DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM | LGD | Substantially Equivalent | |
| K994424 | DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM | LRM | Substantially Equivalent | |
| K993294 | DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM | LKJ | Substantially Equivalent | |
| K981812 | EBV-VCA IGG ELISA TEST SYSTEM | LSE | Substantially Equivalent | |
| K981831 | IS EBV-EA-D IGG ELISA TEST SYSTEM | GNP | Substantially Equivalent | |
| K981829 | IS EBV-EBNA-1 IGG ELISA TEST SYSTEM | GNP | Substantially Equivalent | |
| K981729 | IS-RUBELLA IGG TEST SYSTEM | LFX | Substantially Equivalent | |
| K981306 | DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM | LGC | Substantially Equivalent | |
| K981867 | IS-VZU IGG TEST SYSTEM | LFY | Substantially Equivalent | |
| K981163 | DIAMEDIX IS-CMV IGG TEST SYSTEM | LFZ | Substantially Equivalent | |
| K981498 | IS-TOXOPLASMA IGG TEST SYSTEM | LGD | Substantially Equivalent | |
| K980759 | DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM | LLL | Substantially Equivalent | |
| K974889 | DIAMEDIX IS-RF TEST SYSTEM | DHR | Substantially Equivalent | |
| K974694 | IS-DSDNA TEST SYSTEM | LRM | Substantially Equivalent | |
| K974552 | DIAMEDIX IS-MEASLES IGG TEST SYSTEM | LJB | Substantially Equivalent | |
| K973177 | MAGO AUTOMATED EIA PROCESSOR | JJF | Substantially Equivalent | |
| K970239 | IS-ANTI-SCL-70 TEST SYSTEM (720-280) | LLL | Substantially Equivalent | |
| K970238 | IS-ANTI-SM/RNP (720-270) | LLL | Substantially Equivalent | |
| K970237 | IS-ANTI-SSB TEST SYSTEM (720-260) | LLL | Substantially Equivalent | |
| K970228 | IS-ANTI-JO-1 TEST SYSTEM | LLL | Substantially Equivalent | |
| K970220 | IS-ANTI-SM TEST SYSTEM | LLL | Substantially Equivalent | |
| K970218 | IS-ANTI-SSA TEST SYSTEM | LLL | Substantially Equivalent | |
| K912020 | ANTI-DNA MICROASSAY | LRM | Substantially Equivalent | |
| K911679 | ANTI-JO-1 MICROASSAY | LLL | Substantially Equivalent | |
| K911330 | LYME IGM MICROASSAY | LSR | Substantially Equivalent | |
| K910899 | LYME DISEASE MICROASSAY | LSR | Substantially Equivalent | |
| K903961 | MEASLES IGG MICROASSAY | LJB | Substantially Equivalent | |
| K902915 | ANTI-SCI-70 MICROASSAY | LJM | Substantially Equivalent | |
| K900572 | LYME IGM MICROASSAY | LSR | Substantially Equivalent | |
| K901073 | ANTI-RNP MICROASSAY | LLL | Substantially Equivalent | |
| K900241 | ANTI-SSA MICROASSAY AND ANTI-SSB MICROASSAY | LLL | Substantially Equivalent | |
| K894894 | ANTI-SM MICROASSAY | LJM | Substantially Equivalent | |
| K890843 | LYME DISEASE MICROASSAY | LSR | Substantially Equivalent | |
| K890642 | VZV MICROASSAY | LFY | Substantially Equivalent | |
| K892129 | EZ COMPLEMENT C4 | DBI | Substantially Equivalent | |
| K892127 | EZ COMPLEMENT C3 | CZW | Substantially Equivalent | |
| K892125 | EZ COMPLEMENT C2 | CZW | Substantially Equivalent | |
| K891904 | EZ COMPLEMENT C1 | DAC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JJFAnalyzer, Chemistry, Micro, For Clinical Use
- LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control
- MSTAntibodies, Gliadin
- LKQAntibody Igm,If, Cytomegalovirus Virus
- KHWAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
- LJOAntigen, Iha, Cytomegalovirus
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- LKJAntinuclear Antibody, Antigen, Control
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- GQIAntiserum, Cf, Cytomegalovirus
- GNPAntiserum, Cf, Epstein-Barr Virus
- DAKComplement C1q, Antigen, Antiserum, Control
- CZWComplement C3, Antigen, Antiserum, Control
- DACComplement C3b Activator, Antigen, Antiserum, Control
- DBIComplement C4, Antigen, Antiserum, Control
- GGCControl, Plasma, Abnormal
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- LJBEnzyme Linked Immunoabsorbent Assay, Rubeola Igg
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- LFYEnzyme Linked Immunoabsorbent Assay, Varicella-Zoster
- LSEEpstein-Barr Virus, Other
- LLLExtractable Antinuclear Antibody, Antigen And Control
- DHLProtein, Complement, Antigen, Antiserum, Control
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CEERadioimmunoassay, Thyroxine-Binding Globulin
- LSRReagent, Borrelia Serological Reagent
- MIDSystem, Test, Anticardiolipin Immunological
- DHASystem, Test, Human Chorionic Gonadotropin
- DHRSystem, Test, Rheumatoid Factor
- MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2574-2018 | Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640 | Contains a gel-like contaminant that may affect product performance. | Class III | Terminated | |
| Z-2573-2018 | Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540 | Contains a gel-like contaminant that may affect product performance. | Class III | Terminated | |
| Z-1689-2016 | Diamedix Is-CMV IgG Test Kit | Product contained an incorrect substrate. | Class II | Terminated | |
| Z-1687-2016 | 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 of Mumps infection. | A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. | Class II | Terminated | |
| Z-1686-2016 | 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 Mumps infection. | A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. | Class II | Terminated | |
| Z-1685-2016 | 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 Mumps infection. | A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. | Class II | Terminated | |
| Z-0445-2013 | 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 antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA units (EU) per ml determined by comparison to a Calibrator. | Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification. | Class II | Terminated | |
| Z-1520-2012 | 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 for 96 Tests***C - Corrosive Harmful***Lot No: ***For In Vitro Diagnostic Use***Caution, consult accompanying documents.***Manufacturer***Diamedix***A Subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33127 USA-1-800-327-4565***Biohazard***" The Is-HSV 1&2 IgM test kits are packaged in cardboard boxes with individual components secured within a foam insert. The Diamedix Is-HSV 1&2 IgM Test Kit is intended for the qualitative detection of IgM antibodies to herpes simplex virus (HSV) type 1 and/or type 2 in human serum by indirect enzyme immunoassay. This test can aid in the diagnosis of a primary or reactived infection with HSV. The performance of this assay has not bee established for use in neonates, infants, or on cord blood, and immunocompromised patients. | 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. | Terminated | ||
| Z-1620-2012 | 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 Harmful***Lot No: S0000***For In Vitro Diagnostic Use***Caution, consult accompanying documents***Manufacturer DIAMEDIX***a Subsidiary of IVAX Diagnostics, Inc.***Miami, FL 33127 USA-1-800-327-4565***Biohazard***" For the qualitative screening of human IgG antibodies to extractable nuclear antigens (ENA) in human serum by indirect enzyme immunoassay as an aid in the diagnosis of certain autoimmune disorders. This test system screens for antibodies to Sm, Sm/RNP, SSA, SSB, Scl-70 and Jo-1 in one well. Positive samples should be evaluated further using tests designed for each ENA antibody. | 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. | Terminated | ||
| Z-0607-2009 | 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 assessment of the patient's immunological response to measles virus, to determine the immune status of individuals and, when evaluating paired sera, as an aid in the diagnosis of measles infection. | 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. | Terminated | ||
| Z-1684-2008 | 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 intended for the semi-quantitative detection of IgG antibodies to Gliadin in human serum by indirect enzyme immunoassay as an aid in the diagnosis of celiac disease. | 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. | Terminated | ||
| Z-0541-05 | The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert. | 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. | Terminated | ||
| Z-0513-04 | 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 33127 | The test kit may have the potential to give erroneous results in that it may give higher frequency of equivocal/low positive results. | Terminated | ||
| Z-0325-05 | 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 used either manually or in conjunction with the MAGO Plus or APTUS Automated EIA Processors. The FDA has not cleared this product for use in screening blood or plasma donors. The kit is labeled with an expiration date of Mar 04 and requires storage at 2-8 degree Centigrade.The non conforming kit component is the Conjugate that consists of a glass bottle with red cap containing 30 ml goat anti-human IgG labeled with horseradish peroxidase. | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain