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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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HemosIL AcuStar Anti-Cardiolipin IgM
INSTRUMENTATION LABORATORY COMPANY
0009802008
In Commercial Distribution

  • 08426950496960 ()
0009802008

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
HemosIL AcuStar Anti-Cardiolipin IgG
INSTRUMENTATION LABORATORY COMPANY
0009802004
In Commercial Distribution

  • 08426950496953 ()
0009802004

  • Anticardiolipin antibody 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 IgM III Control 4. 1x 1.2mL prediluted ACA IgM III Calibrator A 5. 1x 1.2mL prediluted ACA IgM III Calibrator B 6. 1x 1.2mL prediluted ACA IgM III Calibrator C 7. 1x 1.2mL prediluted ACA IgM III Calibrator D 8. 1x 1.2mL prediluted ACA IgM III Calibrator E 9. 1x 50mL ACA III Sample Diluent 10. 1x 50mL ACA III PBS Concentrate, 20x concentrate 11. 1x 10mL HRP IgM Conjugate, (goat), anti-human IgM 12. 1x 10mL TMB Chromogen 13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708630
In Commercial Distribution

  • 08426950485988 ()


  • Anticardiolipin antibody 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 IgG III Control 4. 1x 1.2mL prediluted ACA IgG III Calibrator A 5. 1x 1.2mL prediluted ACA IgG III Calibrator B 6. 1x 1.2mL prediluted ACA IgG III Calibrator C 7. 1x 1.2mL prediluted ACA IgG III Calibrator D 8. 1x 1.2mL prediluted ACA IgG III Calibrator E 9. 1x 50mL ACA III Sample Diluent 10. 1x 50mL ACA III PBS Concentrate, 20x concentrate 11. 1x 10mL 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.
708625
In Commercial Distribution

  • 08426950472773 ()


  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
(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)
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 IgA III Control 4. 1x 1.2mL prediluted ACA IgA III Calibrator A 5. 1x 1.2mL prediluted ACA IgA III Calibrator B 6. 1x 1.2mL prediluted ACA IgA III Calibrator C 7. 1x 1.2mL prediluted ACA IgA III Calibrator D 8. 1x 1.2mL prediluted ACA IgA III Calibrator E 9. 1x 50mL ACA III Sample Diluent 10. 1x 50mL ACA III PBS Concentrate, 20x 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.
708635
In Commercial Distribution

  • 08426950448389 ()


  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
1. 1x CCP3 IgG ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted CCP3 IgG ELISA Low Positive 4. 1x 1.2mL prediluted CCP3 IgG ELISA High Positive/Calibrator A 5. 1x 1.2mL prediluted CCP3 IgG ELISA Calibrator B 6. 1x 1.2mL prediluted CCP3 IgG ELISA Calibrator C 7. 1x 1.2mL prediluted CCP3 IgG ELISA Calibrator D 8. 1x 1.2mL prediluted CCP3 IgG ELISA Calibrator E 9. 1x 50mL HRP Sample Diluent 10. 1x 25mL HRP Wash Concentrate, 40x concentrate 11. 1x 10mL HRP CCP3 IgG Conjugate, (goat), anti-human IgG 12. 1x 10mL TMB Chromogen 13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
704535
In Commercial Distribution

  • 08426950448358 ()


  • Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)
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