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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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A rapid, automated, molecular test for the qualitative detection of COVID-19 viral nucleic acid in respiratory specimens.
Alere Scarborough, Inc.
190-000
Not in Commercial Distribution

  • 10811877011269 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of the general public to permit normal breathing while protecting the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire). This is a single-use device.
Hans Hepp GmbH & Co. KG
89115
Not in Commercial Distribution

  • 04007418891158 ()


  • Public face mask, single-use
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of the general public to permit normal breathing while protecting the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire). This is a single-use device.
Hans Hepp GmbH & Co. KG
89114
In Commercial Distribution

  • 04007418891141 ()


  • Public face mask, single-use
No Description
WatMIND USA
RDB10-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (1 Test/Box)
In Commercial Distribution

  • 10810172700090 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
No Description
WatMIND USA
RDB6-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)
In Commercial Distribution

  • 10810172700083 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Townson Trauma Shooting Kit
BOUND TREE MEDICAL, LLC
TTSK-3
In Commercial Distribution

  • 00817617029498 ()
  • 00810094573607 ()
TTSK-3

  • First aid kit, medicated
configurable liquid handling workstation
Tecan Schweiz AG
FREEDOM EVO-2 200 BASE
In Commercial Distribution

  • 07640137480363 ()
30032020

  • Pipetting system IVD
configurable liquid handling workstation
Tecan Schweiz AG
FREEDOM EVO-2 150 BASE
In Commercial Distribution

  • 07640137480356 ()
30032015

  • Pipetting system IVD
configurable liquid handling workstation
Tecan Schweiz AG
FREEDOM EVO-2 100 BASE
In Commercial Distribution

  • 07640137480349 ()
30032010

  • Pipetting system IVD
configurable liquid handling workstation
Tecan Schweiz AG
FREEDOM EVO-2 200 BASE
In Commercial Distribution

  • 07640137480141 ()
30020020

  • Pipetting system IVD
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