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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Strongyloides IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3012
In Commercial Distribution

  • B350GSD0130120 ()
GSD01-3012

  • Strongyloides stercoralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Trichinella spiralis IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3002
In Commercial Distribution

  • B350GSD0130020 ()
GSD01-3002

  • Trichinella spiralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Toxocara canis IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3001
In Commercial Distribution

  • B350GSD0130010 ()
GSD01-3001

  • Toxocara canis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Toxocara canis IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3000
Not in Commercial Distribution

  • B350GSD0130000 ()
GSD01-3000

  • Toxocara canis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Gold Standard Diagnostics Is-Toxoplasma IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
720-300
In Commercial Distribution

  • B3507203000 ()
720-300

  • Toxoplasma gondii immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
6125-300
In Commercial Distribution

  • 00816870024097 ()

  • Width: 7.75 Inch
6125-300B

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
6125-300
In Commercial Distribution

  • 00816870024080 ()

  • Width: 7.75 Inch
6125-300A

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
HPC-300
In Commercial Distribution

  • 00816870020211 ()

  • Width: 2 Inch
HPC-300

  • Helicobacter pylori immunoglobulin A (IgA)/IgG antibody IVD, control
"720-370 Rubella IgM Test Kit"
DIAMEDIX CORPORATION
720-370
In Commercial Distribution

  • 00817273020204 ()


  • Rubella virus immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
"720-360 Rubella IgG Test Kit"
DIAMEDIX CORPORATION
720-360
In Commercial Distribution

  • 00817273020198 ()


  • Rubella virus immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
IgG-coated red blood cells for the control of antiglobulin test; 10ml
Bio-Rad Medical Diagnostics GmbH
816030100
In Commercial Distribution

  • 07611969952502 ()
816030100

  • Immunoglobulin-sensitized reagent red blood cell IVD, control
No Description
DIASORIN MOLECULAR LLC
EL0920G-5
In Commercial Distribution

  • 20816101022193 ()
EL0920G-5

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN MOLECULAR LLC
EL0910G-5
In Commercial Distribution

  • 20816101022155 ()
EL0910G-5

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN MOLECULAR LLC
EL0910G
In Commercial Distribution

  • 20816101022148 ()
EL0910G

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN MOLECULAR LLC
EL0920G
In Commercial Distribution

  • 20816101022186 ()
EL0920G

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Simpli 8mm Pen Needle UltiGuard
ULTIMED, INC.
74505
In Commercial Distribution

  • 30357515745058 ()
  • 20357515745051 ()
  • 00357515710055 ()


  • Cryptosporidium species immunoglobulin G (IgG) antibody IVD, calibrator
Simpli 6mm Pen Needle UltiGuard
ULTIMED, INC.
74503
In Commercial Distribution

  • 30357515745034 ()
  • 20357515745037 ()
  • 00357515710147 ()


  • Cryptosporidium species immunoglobulin G (IgG) antibody IVD, calibrator
No Description
Shenzhen Osto Technology Co.,Ltd.
AST-300J
In Commercial Distribution

  • 06950940802155 ()
  • 06950940802148 ()


  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control
No Description
Shenzhen Osto Technology Co.,Ltd.
AST-300L
In Commercial Distribution

  • 06950940802131 ()
  • 06950940802124 ()


  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control
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
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)
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 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
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)
VIROTROL Chagas (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00125X
In Commercial Distribution

  • 00847661002932 ()
00125X

  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, control
VIROTROL Chagas (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00125
In Commercial Distribution

  • 00847661002925 ()
00125

  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, control
VIROTROL WNV (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00116
In Commercial Distribution

  • 00847661002628 ()
00116

  • West Nile virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
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
No Description
BIOCARE MEDICAL LLC
API3115AA
In Commercial Distribution

  • 00847627004208 ()


  • Adenovirus immunoglobulin G (IgG) antibody IVD, reagent
No Description
BIOCARE MEDICAL LLC
ACI3115B
In Commercial Distribution

  • 00847627003010 ()


  • Adenovirus immunoglobulin G (IgG) antibody IVD, reagent
No Description
BIOCARE MEDICAL LLC
ACI3115A
In Commercial Distribution

  • 00847627003003 ()


  • Adenovirus immunoglobulin G (IgG) antibody IVD, reagent
Mumps Control Slides
EMD Millipore Corporation
5029-5
Not in Commercial Distribution

  • 04053252364068 ()
5029-5

  • Mumps virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
Mumps IFA Kit
EMD Millipore Corporation
3140
Not in Commercial Distribution

  • 04053252329746 ()
3140

  • Mumps virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
Mumps Monoclonal Antibody
EMD Millipore Corporation
5028
Not in Commercial Distribution

  • 04053252282713 ()
5028

  • Mumps virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
AccuDiag™ Schistosoma IgG ELISA - For the qualitative detection of immunoglobulin G (IgG) antibodies to multiple species of the parasitic flatworm Schistosoma in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD8209-35
In Commercial Distribution

  • 00894175000114 ()

  • 96 Tests
8209-35

  • Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Mumps Control Slide
EMD Millipore Corporation
5029
Not in Commercial Distribution

  • 04061839704138 ()
5029

  • Mumps virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
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)
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)
No Description
DIESSE DIAGNOSTICA SENESE SPA
81264
In Commercial Distribution

  • 08033891329631 ()
81264

  • Poliovirus immunoglobulin G (IgG) antibody (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2721-9601-1 G
In Commercial Distribution

  • 04049016028376 ()


  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2691-9601-1 G
Not in Commercial Distribution

  • 04049016028321 ()


  • Influenza A/B virus 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 Instruments Gesellschaft mit beschränkter Haftung
EIA-4245
In Commercial Distribution

  • 04048474042450 ()
EIA-4245

  • 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)
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