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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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Vista COV2T Assay - 00630414605500

Vista COV2T Assay
Siemens Healthcare Diagnostics Inc.
11417414
Not in Commercial Distribution

  • 00630414297613 ()
  • 00630414605500 ()
K7414

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

DV/DM COV2T/CV2T CAL - 00630414605494

DV/DM COV2T/CV2T CAL
Siemens Healthcare Diagnostics Inc.
11417413
Not in Commercial Distribution

  • 00630414297606 ()
  • 00630414605494 ()
KC813

  • SARS-CoV-2 total antibody IVD, calibrator

DV/DM COV2T/CV2T POS/NEG CTRL - 00630414605425

DV/DM COV2T/CV2T POS/NEG CTRL
Siemens Healthcare Diagnostics Inc.
11417415
Not in Commercial Distribution

  • 00630414297620 ()
  • 00630414605425 ()
KC815

  • SARS-CoV-2 total antibody IVD, control

Dimension CV2T Assay - 00630414605418

Dimension CV2T Assay
Siemens Healthcare Diagnostics Inc.
11417412
Not in Commercial Distribution

  • 00630414297590 ()
  • 00630414605418 ()
RF812

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

I-MED KN95 Respirator Mask - 00622554052009

Mini-fiber, high electrostatic filter, filtration efficiency of dust & powder above 95%. Continually repels contamination of blood and saliva. Inner cover sweat absorbant with water resistant outer cover. Low breathing resistance and high filtration efficiency.
I-Med Pharma Inc
5200
In Commercial Distribution

  • 00622554052016 ()
  • 00622554052009 ()
5200

  • Surgical/medical face mask, single-use

I-MED Surgical Mask - 00622554051002

Mask intended to be worn by personnel during medical procedures to protect both the patient and the operating personnel from transfer of microorganisms, body fluids and particulate material transfer
I-Med Pharma Inc
5100
In Commercial Distribution

  • 00622554055017 ()
  • 00622554051002 ()
5100

  • Surgical/medical face mask, single-use

I-MED Nitrile Powder-Free and Latex-Free Gloves - 00622554050005

The I-MED Nitrile Powder-free exam gloves. Durable nitrile material is incredibly soft while providing excellent chemical resistance as well as high virus protection. Enhanced tactile sensitivity allows for accurate work with smaller items.
I-Med Pharma Inc
5000
In Commercial Distribution

  • 00622554050012 ()
  • 00622554050005 ()
5000

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Genabio COVID-19 Rapid Self-Test Kit - 00196852953004

No Description
Genabio Diagnostics Inc.
RA9-E00302
In Commercial Distribution

  • 00196852953004 ()
  • 00196852254316 ()


  • SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid

Genabio COVID-19 Rapid Self-Test Kit - 00196852928675

No Description
Genabio Diagnostics Inc.
RA9-E00305
In Commercial Distribution

  • 00196852254316 ()
  • 00196852928675 ()


  • SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid

Genabio COVID-19 Rapid Self-Test Kit - 00196852195008

No Description
Genabio Diagnostics Inc.
RA9-E00325
In Commercial Distribution

  • 00196852254316 ()
  • 00196852195008 ()


  • SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid
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