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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
Shenzhen Osto Technology Co.,Ltd.
AST-300L
In Commercial Distribution

  • 06950940801875 ()
  • 06950940801868 ()


  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control
No Description
Shenzhen Osto Technology Co.,Ltd.
AST-905D
In Commercial Distribution

  • 06950940801745 ()
  • 06950940801738 ()


  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control
No Description
Shenzhen Osto Technology Co.,Ltd.
AST-2012A
In Commercial Distribution

  • 06950940801608 ()
  • 06950940801592 ()


  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control
No Description
Shenzhen Osto Technology Co.,Ltd.
AST-802B
In Commercial Distribution

  • 06950940801530 ()
  • 06950940801523 ()


  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control
L. pneumophila Slides, Serogroups 1-6, 10 each pack
MARDX DIAGNOSTICS, INC.
30-7102
In Commercial Distribution

  • 05391516746366 ()
30-7102

  • Legionella longbeachae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Leptospira IgG ELISA test is an enzyme immunoassay for the detection of antibodies to Leptospira biflexa (serovar patoc 1) for the serological confirmation of infections in serum and plasma.
DRG International Inc
EIA-4245
In Commercial Distribution

  • 00840239042453 ()
EIA-4245

  • Multiple Leptospira species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The DRG Brucella IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Brucella in human serum and plasma.
DRG International Inc
EIA-3455
In Commercial Distribution

  • 00840239034557 ()
EIA-3455

  • Multiple Brucella species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Leptospira IgG ELISA is intended for the qualitative determination of IgG class antibodies against Leptospira spp. in human serum or plasma (heparin).
DRG International Inc
EIA-5751
In Commercial Distribution

  • 00840239057518 ()
EIA-5751

  • Multiple Leptospira species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2189-9601 G
In Commercial Distribution

  • 04049016027560 ()


  • Multiple Brucella species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Clinitek Novus® calibration kit for use with CLINITEK Novus® automated urine chemistry system
Siemens Healthcare Diagnostics Inc.
10697753
In Commercial Distribution

  • 00630414590950 ()
10697753

  • Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, calibrator
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