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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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AccuDiag ™ ANCA Screen IgG ELISA Kit A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with vasculitis in a clinical specimen, using an enzyme immunoassay (EIA) method. The assayed antibodies may include autoimmune antibodies directed at the glomerular basement membrane (GBM), anti-neutrophil cytoplasmic antibodies to myeloperoxidase (ANCA MPO) and/or anti-neutrophil cytoplasmic antibodies to proteinase-3 (PR3).
Diagnostic Automation, Inc.
DACD-1681-2
In Commercial Distribution

  • 00894175000404 ()

  • 96 Tests/ Kit
1681-2

  • Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA)
AccuDiag ™ SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA). A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-SSB or anti-La antibodies (Sjogren's antibodies) in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD-2556-2
In Commercial Distribution

  • 00894175000220 ()

  • 96 Tests
2556-2

  • SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)
AccuDiag ™ SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) The SS-A Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to SSA in human sera. When performed according to these instructions, the results of this assay may aid in the diagnosis and treatment of autoimmune connective tissue disorders. A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-SSA or anti-Ro antibodies (Sjogren's antibodies) in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD-2555-2
In Commercial Distribution

  • 00894175000213 ()

  • Size Type Text Device Size Text, specify: 96 Tests
2555-2

  • SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)
AccuDiag ™ Mumps IgM A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Mumps virus in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD1411-1
In Commercial Distribution

  • 00894175000060 ()

  • 96 Tests
1411-1

  • Mumps virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
AccuDiag ™ Cytomegalovirus (CMV) IgG is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibodies to cytomegalovirus in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CMV.
Diagnostic Automation, Inc.
DACD 1201-2
In Commercial Distribution

  • 00894175000053 ()

  • 96 Tests
1201-2

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
AccuDiag ™ Rubella IgG ELISA is designed for the qualitative and/or quantitative detection of IgG antibodies to rubella virus in human serum. This test is intended to be used to evaluate single sera for immune status or paired sera to demonstrate seroconversion, and is for In Vitro diagnostic use.
Diagnostic Automation, Inc.
DACD 1301-2
In Commercial Distribution

  • 00894175000039 ()

  • 96 TESTS
1301-2

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
AccuDiag ™ Borrelia burgdorferi IgG/IgM is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of total (IgG and IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
Diagnostic Automation, Inc.
DACD-1423-2
In Commercial Distribution

  • 00894175000022 ()

  • 96 tests
1423-2

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
GF Probe, Single Ended, #2 Handle
A. TITAN INSTRUMENTS, INC.
GF 2 2
In Commercial Distribution

  • 00841685111939 ()


  • Manual dental scaler, reusable
Procellera Single Layer Rx, 2" x 2"
Vomaris Wound Care, Inc.
2" x 2"
In Commercial Distribution

  • 00894318002616 ()
  • 10894318002613 ()
VSR-0202

  • Bioelectric wound dressing
PowerHeal Single Layer, 2" x 2"
Vomaris Wound Care, Inc.
2" x 2"
In Commercial Distribution

  • 00810198031560 ()

  • Length: 2 Inch
  • Width: 2 Inch
PSK-0202

  • Bioelectric wound dressing
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