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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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CHORUS POLIOVIRUS IgG - 08033891329631

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)

Diamedix - 00817273020419

"720-850 Mycoplasma IgG Test Kit"
DIAMEDIX CORPORATION
720-850
In Commercial Distribution

  • 00817273020419 ()


  • Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, control

Diamedix - 00817273020402

"720-830 anti-β2 Glycoprotein I IgG/IgM Test Kit"
DIAMEDIX CORPORATION
720-830
In Commercial Distribution

  • 00817273020402 ()


  • Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, control

Toxoplasma gondii control slides - B502BSB60490

Toxoplasma gondii , control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB60490 ()
BSB 6049

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, control

Toxoplasma gondii Control Slides - B502BSB9416CS0

Toxoplasma gondii Control Slides
BIO SB, INC.
BSB-9416-CS
In Commercial Distribution

  • B502BSB9416CS0 ()
BSB-9416-CS

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, control

Schistosoma mansoni IgG ELISA - 07640158219607

The Schistosoma mansoni ELISA test is a qualitative enzyme immunoassay for the detection of Schistosoma mansoni and Schistosoma haematobium antibodies in human serum samples.
Bordier affinity products S.A.
9600
In Commercial Distribution

  • 07640158219607 ()
9600

  • Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

IMMY - 00816387021152

No Description
Immuno-Mycologics, Inc.
CTA2003
In Commercial Distribution

  • 00816387021152 ()
  • 00816387021169 ()


  • Coccidioides immitis immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

AccuDiag ™ - 00894175000114

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)

LIAISON® EBNA IgG Serum Control Set - 08056771601788

No Description
DIASORIN SPA
310522
Not in Commercial Distribution

  • 08056771601788 ()


  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, control

LIAISON® EBNA IgG Serum Control Set - 08056771102988

No Description
DIASORIN SPA
310522
In Commercial Distribution

  • 08056771102988 ()


  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, control

LIAISON® Control EBNA IgG - 08056771101776

No Description
DIASORIN SPA
310521
In Commercial Distribution

  • 08056771101776 ()


  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, control

Light Diagnostics ™ Mumps Control Slide - 04061839704138

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

IFA HSV-2 IgG Test Sytem - 00845533001564

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

Light Diagnostics ™ Mumps Control Slides - 04053252364068

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

Light Diagnostics™ Mumps IFA Kit - 04053252329746

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

Light Diagnostics ™ Mumps Monoclonal Antibody - 04053252282713

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

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)

Anti-Influenza A/B Virus Pool ELISA (IgG) - 04049016028321

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)

Anti-Brucella abortus ELISA (IgG) - 04049016027560

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)

Poliomyelitis ELISA - 00404847425581

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)

Leptopspira IgG ELISA - 04048474057515

The Leptospira IgG ELISA is intended for the qualitative determination of IgG class antibodies against Leptospira spp. in human serum or plasma (heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-5751
In Commercial Distribution

  • 04048474057515 ()
EIA-5751

  • Multiple Leptospira species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Leptospira IgG ELISA - 04048474042450

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)
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