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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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EliA ß2-Glycoprotein I IgA Well
Phadia AB
DECC055310
In Commercial Distribution

  • 07333066010786 ()
  • 07333066014746 ()
DECC055310

  • Beta-2-glycoprotein I antibody IVD, kit, fluorescent immunoassay
IGF-1-RIA-CT
Diasource Immunoassays S.A. SA
KIP1588
In Commercial Distribution

  • 05400569000520 ()


  • Insulin-like growth factor I (IGF1) IVD, kit, radioimmunoassay
IGF-I CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387979
In Commercial Distribution

  • 00630414973647 ()
LGFCVM

  • Insulin-like growth factor I (IGF1) IVD, control
1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder 2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgG ELISA Control 4. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A 5. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B 6. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C 7. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D 8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E 9. 9x 50mL HRP Sample Diluent 10. 10x 25mL HRP Wash Concentrate, 40x concentrate 11. 10x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG 12. 10x 10mL TMB Chromogen 13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708665.10
In Commercial Distribution

  • 08426950595816 ()


  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
1. 10x B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder 2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgA ELISA Control 4. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator A 5. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator B 6. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator C 7. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator D 8. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator E 9. 9x 50mL HRP Sample Diluent 10. 10x 25mL HRP Wash Concentrate, 40x concentrate 11. 10x 10mL HRP IgA Conjugate, (goat), anti-human IgA 12. 10x 10mL TMB Chromogen 13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708675.10
In Commercial Distribution

  • 08426950594659 ()


  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder 2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgG ELISA Control 4. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A 5. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B 6. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C 7. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D 8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E 9. 9x 50mL HRP Sample Diluent 10. 10x 25mL HRP Wash Concentrate, 40x concentrate 11. 10x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG 12. 10x 10mL TMB Chromogen 13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708665.10L
In Commercial Distribution

  • 08426950594543 ()


  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
1. 10x B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder 2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgM ELISA Control 4. 5x 1.2mL prediluted 2 GPI IgM ELISA Calibrator A 5. 5x 1.2mL prediluted 2 GPI IgM ELISA Calibrator B 6. 5x 1.2mL prediluted 2 GPI IgM ELISA Calibrator C 7. 5x 1.2mL prediluted 2 GPI IgM ELISA Calibrator D 8. 5 x1.2mL prediluted 2 GPI IgM ELISA Calibrator E 9. 9x 50mL HRP Sample Diluent 10. 10x 25mL HRP Wash Concentrate, 40x concentrate 11. 10x 10mL HRP IgM Conjugate, (goat), anti-human IgM 12. 10x 10mL TMB Chromogen 13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708670.10L
In Commercial Distribution

  • 08426950594529 ()


  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted 2 GPI IgA ELISA Control 4. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator A 5. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator B 6. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator C 7. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator D 8. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator E 9. 1x 50mL HRP Sample Diluent 10. 1x 25mL HRP Wash Concentrate, 40x concentrate 11. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA 12. 1x 10mL TMB Chromogen 13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708675.10L
In Commercial Distribution

  • 08426950594482 ()


  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
1. 1x β2 GPI Screen ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted β2 GPI Decision Point 4. 1x 1.2mL prediluted β2 GPI Screening Control 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgGAM Conjugate, (goat), anti-human 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708660
In Commercial Distribution

  • 08426950454472 ()


  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted 2 GPI IgG ELISA Control 4. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A 5. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B 6. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C 7. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D 8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E 9. 1x 50mL HRP Sample Diluent 10. 1x 25mL HRP Wash Concentrate, 40x concentrate 11. 1x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG 12. 1x 10mL TMB Chromogen 13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708665
In Commercial Distribution

  • 08426950451112 ()


  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
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