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. Aptiva Celiac Disease IgA Reagent Cartridge contains reagents to process 250 samples. a. tTG, DGP, and Control paramagnetic particles, preserved. b. Assay Buffer – colored pink, containing protein stabilizers and preservatives. c. PE Tracer IgA – PE labeled anti-human IgA antibody, containing buffer, protein stabilizers and preservative. d. Rehydration Buffer - containing protein stabilizers and preservatives
INOVA DIAGNOSTICS, INC.
724120
In Commercial Distribution

  • 08430793040532 ()


  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex
1. Aptiva Celiac IgG Reagent Cartridge contains reagents to process 200 samples. a. tTG, DGP, and Control paramagnetic particles, preserved. b. Assay Buffer – colored pink, containing protein stabilizers and preservatives. c. PE Tracer IgG – PE labeled anti-human IgG antibody, containing buffer, protein stabilizers and preservative. d. Rehydration Buffer - containing protein stabilizers and preservatives
INOVA DIAGNOSTICS, INC.
724100
In Commercial Distribution

  • 08430793040471 ()


  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex
1. 1 QUANTA Flash h-tTG IgA reagent cartridge 2. 1 Resuspension buffer 3. 1 Transfer pipet
INOVA DIAGNOSTICS, INC.
701100
In Commercial Distribution

  • 08426950601890 ()


  • Tissue transglutaminase antibody IVD, kit, chemiluminescent immunoassay
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. 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. QUANTA Flash LKM-1 reagent cartridge contains the following reagents for 50 determinations: a. LKM-1 coated paramagnetic beads, lyophilized. b. Assay buffer – colored pink, containing protein stabilizers and preservatives. c. Tracer IgG – Isoluminol labeled anti-human IgG antibody, containing buffer, protein stabilizers and preservative. 2. Resuspension buffer - colored clear, containing buffer, protein stabilizers and preservatives."
INOVA DIAGNOSTICS, INC.
701298
In Commercial Distribution

  • 08426950767008 ()


  • Liver-kidney microsome 1 antibody (anti-LKM1) IVD, kit, chemiluminescent immunoassay
1. 1 QUANTA Flash CCP3 Reagent Cartridge 2. 1 Resuspension Buffer 6 3. 1 Transfer pipet
INOVA DIAGNOSTICS, INC.
701125
In Commercial Distribution

  • 08426950622208 ()


  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay
1. 10x h-tTG IgG ELISA microwell plates (12-1 x 8 wells), with holder 2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted h-tTG IgG ELISA Low Positive 4. 5x 1.2mL prediluted h-tTG IgG ELISA High Positive 5. 9x 50mL HRP Sample Diluent 6. 10x 25mL HRP Wash Concentrate, 40x concentrate 7. 10x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 10x 10mL TMB Chromogen 9. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708755.10
In Commercial Distribution

  • 08426950596158 ()


  • Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)
1. 1x h-tTG 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 Screen ELISA Low Positive 4. 1x 1.2mL prediluted h-tTG Screen ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP h-tTG IgG/IgA Conjugate, (goat), anti-human IgG and IgA 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
704570
In Commercial Distribution

  • 08426950595922 ()


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