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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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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
The Trichinella spiralis IgG ELISA is intended for the qualitative determination of IgG class antibodies against Trichinella spiralis in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
TRIG0480
In Commercial Distribution

  • ENTITRIG04800 ()
TRIG0480

  • Trichinella spiralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Toxocara canis IgG ELISA is intended for the qualitative determination of IgG class antibodies against Toxocara canis in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
TOCG0450
In Commercial Distribution

  • ENTITOCG04500 ()
TOCG0450

  • Toxocara canis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Strongyloides ELISA is intended for the qualitative determination of antibodies against Strongyloides in human serum or plasma (citrate or heparin).
Gold Standard Diagnostics Frankfurt GmbH
STRO0690
In Commercial Distribution

  • ENTISTRO06900 ()
STRO0690

  • Strongyloides stercoralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Schistosoma mansoni IgG ELISA is intended for the qualitative determination of IgG class antibodies against Schistosoma mansoni in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
SCHG0410
In Commercial Distribution

  • ENTISCHG04100 ()
SCHG0410

  • Schistosoma mansoni immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS IFA Herpes Simplex Virus-2 (HSV-2) IgG Test System is designed for the qualitative and semi-quantitative detection of Herpes Virus Hominis Antibody in human serum by the indirect fluorescent (IFA) technique and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
FA9052G
In Commercial Distribution

  • 00845533001564 ()
FA9052G

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
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 Poliomyelitis Virus IgG ELISA has been designed for the detection and the quantitative determination of specific IgG antibodies against Polio Serotypes 1 and 3 in serum and plasma.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2558
Not in Commercial Distribution

  • 00404847425581 ()
EIA-2558

  • Poliovirus immunoglobulin G (IgG) antibody (serotypes PV1-PV3) 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)
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