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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. 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)
1. 25 x Monkey Oesophagus – 10-well slide 2. 1 x 1mL Pemphigus Positive Control (prediluted) 3. 1 x 1mL Endomysial (Celiac) Positive Control (prediluted) 4. 1 x 1mL IFA System Negative Control (prediluted) 5. 1 x 15mL FITC IgG (H&L), monkey adsorbed Conjugate 6. 1 x 15mL Anti-Human IgA (α) AFF FITC 7. 1 x 3mL 1% Evans Blue Counterstain 8. 2 x 25mL PBS II concentrate (x40) 9. 1 x 10mL Mounting Medium 10. 25 x Coverslips 11. 1 x instruction leaflet
INOVA DIAGNOSTICS, INC.
704150
In Commercial Distribution

  • 08426950557586 ()


  • Skin antibody IVD, kit, fluorescent immunoassay
  • Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
1. 25 x Monkey Oesophagus – 10-well slide 2. 1 x 1mL Endomysial (Celiac) Positive Control (prediluted) 3. 1 x 1mL IFA System Negative Control (prediluted) 4. 2 x 15mL Anti-Human IgA AFF FITC 5. 1 x 3mL 1% Evans Blue Counterstain 6. 2 x 25mL PBS II concentrate (x40) 7. 1 x 10mL Mounting Medium 8. 25 x Coverslips 9. 1 x instruction leaflet
INOVA DIAGNOSTICS, INC.
704155
In Commercial Distribution

  • 08426950553687 ()


  • Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
1. 1 QUANTA Flash h-tTG IgA reagent cartridge 2. 1 Resuspension buffer 3. 1 Transfer pipet
INOVA DIAGNOSTICS, INC.
701103
In Commercial Distribution

  • 08426950544470 ()


  • Tissue transglutaminase antibody IVD, kit, chemiluminescent immunoassay
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. Ready to use. 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. Ready to use. 8.ELISA Negative Control: 1 bottle 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: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgA. Colored yellow. Ready to use. 10. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. Ready to use. 11.Stop Solution HRP: 1 bottle containing 10mL of 0.344M Sulfuric Acid. Ready to use.
INOVA DIAGNOSTICS, INC.
704605
In Commercial Distribution

  • 08426950544463 ()


  • Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)
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