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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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Novation Ceramic AHS - 10885862025463

No Description
Exactech, Inc.
140-32-12
Not in Commercial Distribution

  • 10885862025463 ()

  • Lumen/Inner Diameter: 32 Millimeter
  • Group 2
140-32-12

  • Ceramic acetabular liner

Novation Ceramic AHS - 10885862025418

No Description
Exactech, Inc.
140-28-11
Not in Commercial Distribution

  • 10885862025418 ()

  • Group 1
  • Lumen/Inner Diameter: 28 Millimeter
140-28-11

  • Ceramic acetabular liner

West Nile Virus IgG DxSelect™ - IgG Antigen Wells - 10816101022349

No Description
DIASORIN MOLECULAR LLC
EL0351
In Commercial Distribution

  • 10816101022349 ()
EL0351

  • West Nile virus immunoglobulin G (IgG) antibody IVD, reagent

West Nile Virus IgG DxSelect™ - IgG Conjugate - 10816101022318

No Description
DIASORIN MOLECULAR LLC
EL0304
In Commercial Distribution

  • 10816101022318 ()
EL0304

  • West Nile virus immunoglobulin G (IgG) antibody IVD, reagent

HSV Serum Panel - 10816101022202

No Description
DIASORIN MOLECULAR LLC
EL0950
In Commercial Distribution

  • 10816101022202 ()
EL0950

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, control

PreciControl HSV - 04015630939039

No Description
Roche Diagnostics GmbH
5572207160
In Commercial Distribution

  • 04015630939039 ()
5572207160

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, control

Surpass Acetabular system - 10840843106661

No Description
GLOBUS MEDICAL, INC.
SC2644-32-58
Not in Commercial Distribution

  • 10840843106661 ()


  • Ceramic acetabular liner

Surpass Acetabular system - 10840843106654

No Description
GLOBUS MEDICAL, INC.
SC2643-32-52
Not in Commercial Distribution

  • 10840843106654 ()


  • Ceramic acetabular liner

Surpass Acetabular system - 10840843106647

No Description
GLOBUS MEDICAL, INC.
SC2642-28-46
Not in Commercial Distribution

  • 10840843106647 ()


  • Ceramic acetabular liner

Measles Virus IgG Avidity ELISA - 04048474059670

The Measles Virus IgG Avidity ELISA is intended to indicate the Measles-specific IgG avidity in human serum or plasma (citrate, heparin) to differentiate between acute and past infection.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-5967
Not in Commercial Distribution

  • 04048474059670 ()
EIA-5967

  • Measles virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Mumps IgM ELISA - 04048474038477

The Mumps Virus IgM ELISA is intended for the qualitative determination of IgM class antibodies against Mumps Virus in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3847
In Commercial Distribution

  • 04048474038477 ()
EIA-3847

  • Mumps virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Mumps Virus IgG ELISA - 04048474038460

The Mumps Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Mumps Virus in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3846
In Commercial Distribution

  • 04048474038460 ()
EIA-3846

  • Mumps virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Measles Virus IgG ELISA - 04048474038446

The Measles Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Measles Virus in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3844
In Commercial Distribution

  • 04048474038446 ()
EIA-3844

  • Measles virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Respiratory Syncytial Virus Antigen Substrate, 12 wells, For IFA Test System - B110RS90120

No Description
Bion Enterprises, Ltd.
RS-9012
In Commercial Distribution

  • B110RS90120 ()
RS-9012

  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, reagent

EBV Nuclear Antigen (EBNA) Substrate, 12 wells, For ACIF Test System - B110NA51120

No Description
Bion Enterprises, Ltd.
NA-5112
Not in Commercial Distribution

  • B110NA51120 ()
NA-5112

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, reagent

Influenza B Virus Antigen Substrate, 12 wells, For IFA Test System - B110IB21120

No Description
Bion Enterprises, Ltd.
IB-2112
In Commercial Distribution

  • B110IB21120 ()
IB-2112

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, reagent

Influenza A Virus Antigen Substrate, 12 wells, For IFA Test System - B110IA11120

No Description
Bion Enterprises, Ltd.
IA-1112
In Commercial Distribution

  • B110IA11120 ()
IA-1112

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, reagent

Herpes Simplex IgG Control - B110HSG35200

No Description
Bion Enterprises, Ltd.
HSG-3520
In Commercial Distribution

  • B110HSG35200 ()
HSG-3520

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, control

Toxoplasma gondii RPab - B502BSB60480

Anti-Toxoplasma is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB60480 ()
BSB 6048

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

Toxoplasma gondii RPab - B502BSB60470

Anti-Toxoplasma is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB60470 ()
BSB 6047

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