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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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Pointe Scientific, Inc. Toxoplasma IgG - 00811727015150

Pointe Scientific, Inc. Toxoplasma IgG Reagent is for the qualitative, semi-quantitative or quantitative detection of human IgG antibodies to Toxoplasma gondii in human serum by enzyme immunoassay, as an aid in the determination of infection with Toxoplasma. When used as a qualitative test, Toxoplasma IgG EIA aids in the assessment of the patient's immunological response to toxoplasma. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests
POINTE SCIENTIFIC, INC.
T8001-96
In Commercial Distribution

  • 00811727015150 ()
T81001-96

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Simpli - 20357515745051

Simpli 8mm Pen Needle UltiGuard
ULTIMED, INC.
74505
In Commercial Distribution

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


  • Cryptosporidium species immunoglobulin G (IgG) antibody IVD, calibrator

Simpli - 20357515745037

Simpli 6mm Pen Needle UltiGuard
ULTIMED, INC.
74503
In Commercial Distribution

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


  • Cryptosporidium species immunoglobulin G (IgG) antibody IVD, calibrator

HerpeSelect® 2 ELISA IgG - 20816101022193

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)

HerpeSelect® 2 ELISA IgG - 20816101022186

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)

HerpeSelect® 1 ELISA IgG - 20816101022155

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)

HerpeSelect® 1 ELISA IgG - 20816101022148

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)

NovaLisa Trichinella spiralis IgG - ENTITRIG04800

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)

NovaLisa Toxocara canis IgG - ENTITOCG04500

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)

NovaLisa Strongyloides - ENTISTRO06900

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)

NovaLisa Schistosoma mansoni IgG - ENTISCHG04100

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)

VEVOR - 06950940802148

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

VEVOR - 06950940802124

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

N/A - 06950940801868

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

OSITO - 06950940801738

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

OSITO - 06950940801592

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

OSITO - 06950940801523

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

Trinity Biotech - 05391516746366

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)

Leptopspira IgG ELISA - 00840239042453

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)

Brucella IgG ELISA - 00840239034557

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)

Leptospira IgG ELISA - 00840239057518

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)

IFA Mosaic: Coxsackie virus A Types (IgG) - 04049016080787

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-2010-2 G
In Commercial Distribution

  • 04049016080787 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

IFA Mosaic: Coxsackie virus Type A7 / Type B1 (IgG) - 04049016061489

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-1010-4 G
In Commercial Distribution

  • 04049016061489 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

IFA Mosaic: Coxsackie virus Type A7 / Type B1 (IgG) - 04049016061472

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-1005-4 G
In Commercial Distribution

  • 04049016061472 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

IFA Mosaic: Coxsackie virus B Types (IgG) - 04049016061335

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-2005-3 G
In Commercial Distribution

  • 04049016061335 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

IFA Mosaic: Coxsackie virus B Types (IgG) - 04049016061311

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-1005-3 G
In Commercial Distribution

  • 04049016061311 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

IFA Mosaic: Coxsackie virus A Types (IgG) - 04049016061175

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-2005-2 G
In Commercial Distribution

  • 04049016061175 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

IFA Mosaic: Coxsackie virus A Types (IgG) - 04049016061151

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-1005-2 G
In Commercial Distribution

  • 04049016061151 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

IFA Mosaic: Coxsackie virus (IgG) - 04049016060994

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-1005-1 G
In Commercial Distribution

  • 04049016060994 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Anti-Parainfluenza Viruses Pool ELISA (IgG) - 04049016028376

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)
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