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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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No Description
DIASORIN MOLECULAR LLC
EL0300G
In Commercial Distribution

  • 20816101022001 ()
EL0300G

  • West Nile virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Mycoplasma pneumoniae IgG ELISA is intended for the qualitative determination of IgG class antibodies against Mycoplasma pneumoniae in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
MYCG0350
In Commercial Distribution

  • ENTIMYCG03500 ()
MYCG0350

  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
INFG0300
In Commercial Distribution

  • ENTIINFG03000 ()
INFG0300

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Influenza Virus A IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus A in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
INFG0290
In Commercial Distribution

  • ENTIINFG02900 ()
INFG0290

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The SeroELISA Chlamydia IgG kit is intended for the determination of specific IgG antibody to Chlamydia in a single human serum sample or to evaluate paired sera, by an Enzyme-Linked Immunosorbent Assay (ELISA).
SAVYON DIAGNOSTICS LTD
A111-01
In Commercial Distribution

  • 07290001913147 ()
A111-01

  • Chlamydia pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The DG Gel 8 T/S Mono card is for the determination of human A, B and D antigens on the surface of red blood cells, and for Indirect Antiglobulin Test of human blood samples. This test does not contain antibodies to complement components. For use with the DG Gel System. For in vitro diagnostic use.
DIAGNOSTIC GRIFOLS SA
210391
Not in Commercial Distribution

  • 08437014205053 ()
210391

  • ABO/Rh multiple blood grouping IVD, kit, agglutination
  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
PneumoTrol (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00129
In Commercial Distribution

  • 00847661002734 ()
00129

  • Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, control
  • Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, control
  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, control
No Description
SEBIA
4642
In Commercial Distribution

  • 03607360046425 ()
4642

  • Multiple clinical chemistry protein IVD, reagent
No Description
SEBIA
4639
In Commercial Distribution

  • 03607360046395 ()
4639

  • Multiple clinical chemistry protein IVD, reagent
No Description
SEBIA
2602
In Commercial Distribution

  • 03607360026021 ()
2602

  • Multiple clinical chemistry protein IVD, reagent
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