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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 Class Implantable

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VITROS - 10758750034581

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators
ORTHO-CLINICAL DIAGNOSTICS, INC.
6199976
In Commercial Distribution

  • 10758750034581 ()
6199976

  • SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay

VITROS - 10758750034420

VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Calibrator
ORTHO CLINICAL DIAGNOSTICS
6199961
In Commercial Distribution

  • 10758750034420 ()
6199961

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

VITROS - 10758750033591

VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator
ORTHO-CLINICAL DIAGNOSTICS, INC.
6199950
In Commercial Distribution

  • 10758750033591 ()
6199950

  • SARS-CoV-2 antigen IVD, kit, chemiluminescent immunoassay

VITROS - 10758750033560

VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Controls
ORTHO-CLINICAL DIAGNOSTICS, INC.
6199943
In Commercial Distribution

  • 10758750033560 ()
6199943

  • SARS-CoV-2 antigen IVD, control

YUCERA - 06974242680150

No Description
Shenzhen Yurucheng Dental Materials Co., Ltd.
95×20
In Commercial Distribution

  • 06974242680150 ()


  • Dental appliance fabrication material, ceramic

YUCERA - 06974242680051

No Description
Shenzhen Yurucheng Dental Materials Co., Ltd.
98×20
In Commercial Distribution

  • 06974242680051 ()


  • Dental appliance fabrication material, ceramic

Alinity - 00380740193829

AdviseDx SARS-CoV-2 IgG II Control Kit
Abbott Ireland Diagnostics
06S6110
In Commercial Distribution

  • 00380740193829 ()
06S6110

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

Alinity - 00380740193805

AdviseDx SARS-CoV-2 IgG II Calibrator Kit
Abbott Ireland Diagnostics
06S6101
In Commercial Distribution

  • 00380740193805 ()
06S6101

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator

ARCHITECT - 00380740193744

AdviseDx SARS-CoV-2 IgG II Control Kit
Abbott Ireland Diagnostics
06S6010
In Commercial Distribution

  • 00380740193744 ()
06S6010

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

ARCHITECT - 00380740193720

AdviseDx SARS-CoV-2 IgG II Calibrator Kit
Abbott Ireland Diagnostics
06S6001
In Commercial Distribution

  • 00380740193720 ()
06S6001

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
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