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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 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
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
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)
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)
For the qualitative screening of serum or plasma IgG antibodies to Taenia solium using an Enzyme Linked Immunoabsorbant Assay (ELISA) technique.NLD
DRG International Inc
EIA-3513
In Commercial Distribution

  • 00840239035134 ()
EIA-3513

  • Taenia solium immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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)
This ELISA is an in vitro immunoassay for the qualitative determination of E. histolytica antigen in feces
DRG International Inc
EIA-3473
Not in Commercial Distribution

  • 00840239034731 ()
EIA-3473

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Entamoeba histolytica IgG ELISA is intended for the qualitative determination of IgG class antibodies against Entamoeba histolytica in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-3830
In Commercial Distribution

  • 00840239038302 ()
EIA-3830

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The RIDASCREEN® Taenia solium IgG test is an enzyme immunoassay for the qualitative determination of IgG antibodies against Taenia solium and its cysticerci (bladder worms) in human serum. The test should be used for confirmation purposes when there is a suspected case of infection with Taenia solium.
R-Biopharm AG
K7721
Not in Commercial Distribution

  • 04049095110528 ()
K7721

  • Taenia solium immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The RIDASCREEN® Entamoeba histolytica IgG test is an enzyme immunoassay for the qualitative determination of IgG antibodies against Entamoeba histolytica in human serum. The test should be used for confirmation purposes when there is a suspected case of amoebiasis.
R-Biopharm AG
K1721
Not in Commercial Distribution

  • 04049095110023 ()
K1721

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
DY 2133-24001 G
In Commercial Distribution

  • 04049016126010 ()


  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
DY 2133-3001 G
In Commercial Distribution

  • 04049016126003 ()


  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2050-9601 G
Not in Commercial Distribution

  • 04049016085508 ()


  • Bordetella pertussis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
DN 2050-24001 G
In Commercial Distribution

  • 04049016085478 ()


  • Bordetella pertussis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
DN 2050-1601 G
In Commercial Distribution

  • 04049016085447 ()


  • Bordetella pertussis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2320-2005 G
Not in Commercial Distribution

  • 04049016055655 ()


  • Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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