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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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1. 10x ACA IgG III ELISA microwell plates (12-1 x 8 wells), with holder 2. 5x 1.2mL prediluted ACA Negative Control 3. 5x 1.2mL prediluted ACA IgG III Control 4. 5x 1.2mL prediluted ACA IgG III Calibrator A 5. 5x 1.2mL prediluted ACA IgG III Calibrator B 6. 5x 1.2mL prediluted ACA IgG III Calibrator C 7. 5x 1.2mL prediluted ACA IgG III Calibrator D 8. 5x 1.2mL prediluted ACA IgG III Calibrator E 9. 9x 50mL ACA III Sample Diluent 10. 10x 50mL ACA III PBS Concentrate, 20x concentrate 11. 10x 10mL ACA IgG III Conjugate, (goat), anti-human IgG 12. 10x 10mL TMB Chromogen 13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708625.10L
In Commercial Distribution

  • 08426950594123 ()


  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
1. 1x F-Actin ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted F-Actin IgA ELISA Low Positive 4. 1 x1.2mL prediluted F-Actin IgA ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgA Conjugate, (goat), anti -human IgA 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
704500
In Commercial Distribution

  • 08426950594093 ()


  • F-Actin antibody IVD, kit, enzyme immunoassay (EIA)
1. 10x ACA IgM III ELISA microwell plates (12-1 x 8 wells), with holder 2. 5x 1.2mL prediluted ACA Negative Control 3. 5x 1.2mL prediluted ACA IgM III Control 4. 5x 1.2mL prediluted ACA IgM III Calibrator A 5. 5x 1.2mL prediluted ACA IgM III Calibrator B 6. 5x 1.2mL prediluted ACA IgM III Calibrator C 7. 5x 1.2mL prediluted ACA IgM III Calibrator D 8. 5x 1.2mL prediluted ACA IgM III Calibrator E 9. 9x 50mL ACA III Sample Diluent 10. 10x 50mL ACA III PBS Concentrate, 20x concentrate 11. 10x 10mL HRP ACA IgM Conjugate, (goat), anti-human IgM 12. 10x 10mL TMB Chromogen 13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708630.10L
In Commercial Distribution

  • 08426950594062 ()


  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
1. Instruction leaflet: Giving full assay details. 2. QC Certificate: Indicating the expected performance of the batch. 3. Human Transglutaminase Coated Wells: 12 breakapart 8 well strips coated with recombinant tTG. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches. 4. HRP Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored pink, 5. HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells. 6. R h-tTG IgG Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-tTG IgG autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. 7. R h-tTG IgG Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. 8. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. 9. HRP R h-tTG IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. 10. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. 11. Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric Acid.
INOVA DIAGNOSTICS, INC.
704610.10L
In Commercial Distribution

  • 08426950593928 ()


  • Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)
1. 10 CCP3.1 IgG/IgA ELISA microwell plate (12-1 x 8 wells), with holder 2. 5 1.2mL prediluted ELISA Negative Control 3. 5 1.2mL prediluted CCP3.1 IgG/IgA ELISA Low Positive 4. 5 1.2mL prediluted CCP3.1 IgG/IgA ELISA High Positive/Calibrator A 5. 5 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator B 6. 5 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator C 7. 5 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator D 8. 5 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator E 9. 9 50mL HRP Sample Diluent 10. 10 100mL High Specificity Wash Concentrate, 10x concentrate 11. 10 10mL HRP CCP3.1 IgG/IgA Conjugate, (goat), anti-human IgG/IgA 12. 10 10mL TMB Chromogen 13. 10 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
704550.10
In Commercial Distribution

  • 08426950593690 ()


  • Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)
1. Instruction leaflet: Giving full assay details. 2.QC Certificate: Indicating the expected performance of the batch. 3. Human Transglutaminase Coated Wells: 12 breakapart 8 well strips coated with recombinant tTG. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches. 4. HRP Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored pink, ready to use. 5. HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells. 6. R h-tTG IgA Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-tTG IgA autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. 7.R h-tTG IgA Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. 8.ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate.. 9. HRP R h-tTG IgA Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgA. Colored yellow. 10. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. 11.Stop Solution HRP: 1 bottle containing 10mL of 0.344M Sulfuric Acid.
INOVA DIAGNOSTICS, INC.
704605.10L
In Commercial Distribution

  • 08426950593560 ()


  • Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)
1. Instruction leaflet: Giving full assay details. 2.QC Certificate: Indicating the expected performance of the batch. 3. Human Transglutaminase Coated Wells: 10 plates containing 12 breakapart 8 well strips coated with recombinant tTG. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches. 4. HRP Sample Diluent: 19 bottles containing 50mL of buffer for sample dilution. Colored pink, ready to use. 5. HRP Wash Concentrate: 10 bottles containing 25mL of a 40-fold concentrated buffer for washing the wells. 6. R h-tTG IgA Calibrators: 25 bottles (5 bottles each), containing 1.2mL of diluted human serum, with the following concentrations of anti-tTG IgA autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. Ready to use. 7. R h-tTG IgA Positive Control: 5 bottles containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use. 8. ELISA Negative Control: 5 bottles containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use. 9. HRP R h-tTG IgA Conjugate: 10 bottles containing 10mL of purified peroxidase labelled antibody to human IgA. Colored yellow. Ready to use. 10. TMB Chromogen: 10 bottles containing 10mL TMB chromogen. Ready to use. 11. HRP Stop Solution: 10 bottles containing 10mL of 0.344M Sulfuric Acid. Ready to use.
INOVA DIAGNOSTICS, INC.
704605.10
In Commercial Distribution

  • 08426950593447 ()


  • Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)
1. 10x CCP3 IgG ELISA microwell plates (12-1 x 8 wells), with holder 2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted CCP3 IgG ELISA Low Positive 4. 5x 1.2mL prediluted CCP3 IgG ELISA High Positive/Calibrator A 5. 5x 1.2mL prediluted CCP3 IgG ELISA Calibrator B 6. 5x 1.2mL prediluted CCP3 IgG ELISA Calibrator C 7. 5x 1.2mL prediluted CCP3 IgG ELISA Calibrator D 8. 5x 1.2mL prediluted CCP3 IgG ELISA Calibrator E 9. 9x 50mL HRP Sample Diluent 10. 10x 25mL HRP Wash Concentrate, 40x concentrate 11. 10x 10mL HRP CCP3 IgG Conjugate, (goat), anti-human IgG 12. 10 x10mL TMB Chromogen 13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
704535.10
In Commercial Distribution

  • 08426950593393 ()


  • Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)
1. 1x h-tTG/DGP Screen ELISA microwell plate (12-1 x 8 wells), with holder 2.1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted h-tTG/DGP Screen ELISA Low Positive 4. 1x 1.2mL prediluted h-tTG/DGP Screen ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP h-tTG/DGP IgG/IgA, (goat), anti-human IgG and IgA 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
704575
In Commercial Distribution

  • 08426950593300 ()


  • Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA)
1. 1x LKM-1 ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted LKM-1 ELISA Low Positive 4. 1x 1.2mL prediluted LKM-1 ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708745
In Commercial Distribution

  • 08426950593201 ()


  • Liver-kidney microsome 1 antibody (anti-LKM1) IVD, kit, enzyme immunoassay (EIA)
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