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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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Radial immunodiffusion plate package for human IgM
KENT LABORATORIES INC
1
In Commercial Distribution

  • B176103411 ()
103411

  • Total immunoglobulin M (IgM total) IVD, antibody
IMMAGE Immunochemistry Systems IGA Immunoglobulin A Reagent
Beckman Coulter, Inc.
446460
In Commercial Distribution

  • 15099590230470 ()
446460

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
IgM
Beckman Coulter, Inc.
OSR61173
In Commercial Distribution

  • 15099590011598 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
IgA
Beckman Coulter, Inc.
OSR61171
In Commercial Distribution

  • 15099590011574 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
IMMAGE Immunochemistry Systems IGALC Low Concentration ImmunoglobuIin A
Beckman Coulter, Inc.
447460
In Commercial Distribution

  • 15099590221225 ()
447460

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M
Beckman Coulter, Inc.
447470
In Commercial Distribution

  • 15099590221218 ()
447470

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent
Beckman Coulter, Inc.
447610
In Commercial Distribution

  • 15099590221195 ()
447610

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
B. burgdorferi (IgG) Marblot Strip Test System (400 Tests)
MARDX DIAGNOSTICS, INC.
40-5065G/B-A
In Commercial Distribution

  • 05391516747967 ()
40-5065G/B-A

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
B. burgdorferi 10 Well Slides, 10 each pack
MARDX DIAGNOSTICS, INC.
32-5010
In Commercial Distribution

  • 05391516747608 ()
32-5010

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Borrelia burgdorferi EIA IgG
CLARK LABORATORIES, INC.
40-8696G
In Commercial Distribution

  • 05391516746625 ()

  • 96 Tests
40-8696G

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
B. burgdorferi EIA (IgG) Test System (96 Tests)
MARDX DIAGNOSTICS, INC.
40-8696G
In Commercial Distribution

  • 05391516746267 ()
40-8696G

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
B. burgdorferi (IgG) Marblot Strip Test System (400 Tests)
MARDX DIAGNOSTICS, INC.
40-5065G/B
In Commercial Distribution

  • 05391516746236 ()
40-5065G/B

  • Borrelia garinii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
B. burgdorferi (IgG) Marblot Strip Test System (50 Tests)
MARDX DIAGNOSTICS, INC.
40-5065G
In Commercial Distribution

  • 05391516746229 ()
40-5065G

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
B. burgdorferi (IgG) Marblot Strip Test System (20 Tests)
MARDX DIAGNOSTICS, INC.
40-2075G
In Commercial Distribution

  • 05391516746205 ()
40-2075G

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
CAPTIA™ Syphilis (T. Pallidum)-G
CLARK LABORATORIES, INC.
800-960
In Commercial Distribution

  • 05391516744836 ()

  • 960 Tests
800-960

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
CAPTIA™Syphilis (T. Pallidum)-G
CLARK LABORATORIES, INC.
800-970
In Commercial Distribution

  • 05391516744829 ()

  • 96 Tests
800-970

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
Syphilis G
In Commercial Distribution

  • 00850487007609 ()
Q01-580

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
Syphilis G
In Commercial Distribution

  • 00850487007043 ()
Q01-580

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN MOLECULAR LLC
IB0901
In Commercial Distribution

  • 10816101021014 ()
IB0901

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, reagent
The E. histolytica ELISA test is a qualitative enzyme immunoassay for the detection of antibodies to E. histolytica, in samples of human serum or plasma.
DRG International Inc
EIA-3474
In Commercial Distribution

  • 00840239034748 ()

  • Positive Control
  • Stop Solution
  • Chromogen TMB
  • Total Volume: 11 Milliliter
  • Total Volume: 1 Milliliter
  • Total Volume: 30 Milliliter
  • Enzyme Conjugate
  • Total Volume: 25 Milliliter
  • Negative Control
  • Wash Concentrate
  • Dilution Buffer
EIA-3474

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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