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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. 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)
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 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. Ready to use. 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. 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 IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. Ready to use. 10. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. Ready to use. 11. Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric Acid. Ready to use.
INOVA DIAGNOSTICS, INC.
704610
In Commercial Distribution

  • 08426950544142 ()


  • Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)
(S. cerevisiae) 1. 1x ASCA IgA ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ASCA IgA ELISA Low Positive 4. 1x 1.2mL prediluted ASCA 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. 1x10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708870
In Commercial Distribution

  • 08426950514213 ()


  • Saccharomyces cerevisiae immunoglobulin A (IgA) antibody IVD, kit enzyme immunoassay (EIA)
(S. cerevisiae) 1. 1x ASCA IgG ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ASCA IgG ELISA Low Positive 4. 1x 1.2mL prediluted ASCA IgG 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.
708865
In Commercial Distribution

  • 08426950514206 ()


  • Saccharomyces cerevisiae immunoglobulin G (IgG) antibody IVD, kit enzyme immunoassay (EIA)
1. 10 x Monkey Oesophagus – 5-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 7mL FITC IgG (H&L), monkey adsorbed Conjugate 6. 1 x 7mL 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 3mL Mounting Medium 10. 10 x Coverslips 11. 1 x instruction leaflet
INOVA DIAGNOSTICS, INC.
704145
In Commercial Distribution

  • 08426950513988 ()


  • Skin antibody IVD, kit, fluorescent immunoassay
  • Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
(Human Tissue Transglutaminase) 1. 1x ANA ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ANA ELISA Low Positive 4. 1x 1.2mL prediluted ANA ELISA High Positive 5. 1x 50mL ANA Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HS 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.
708755
In Commercial Distribution

  • 08426950456131 ()


  • Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)
1. 1x CCP3.1 IgG/IgA ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Low Positive 4. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA High Positive/Calibrator A 5. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator B 6. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator C 7. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator D 8. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator E 9. 1x 50mL HRP Sample Diluent 10. 1x 100mL High Specificity Wash Concentrate, 10x concentrate 11. 1x 10mL HRP CCP3.1 IgG/IgA Conjugate, (goat), anti-human IgG/IgA 12. 1x 10mL TMB Chromogen 13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
704550
In Commercial Distribution

  • 08426950456124 ()


  • Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)
1. 1x Cardiolipin ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ACA Negative Control 3. 1x 1.2mL prediluted ACA III Decision Point 4. 1x 1.2mL prediluted ACA III Screen Control 5. 1x 50mL ACA III Sample Diluent 6. 1x 50mL ACA III PBS Concentrate, 20x concentrate 7. 1x 10mL HRP IgGAM Conjugate, (goat), anti-human IgGAM 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708620
In Commercial Distribution

  • 08426950454489 ()


  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
(Human Tissue Transglutaminase) 1. 1x h-tTG IgA 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 IgA ELISA Low Positive 4. 1x 1.2mL prediluted h-tTG 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.
708760
In Commercial Distribution

  • 08426950454380 ()


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