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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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Control swabs intended for use only with BinaxNOW COVID-19 Ag product manufactured by Abbott Diagnostics Scarborough, Inc.
Alere Scarborough, Inc.
195-080
In Commercial Distribution

  • 10811877011306 ()


  • SARS-CoV-2 antigen IVD, control
The BinaxNOW COVID-19 Ag Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals who are suspected of COVID-19 by their healthcare provider.
Alere Scarborough, Inc.
195-000
In Commercial Distribution

  • 10811877011290 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Control Swabs intended for use only with the ID NOW™ COVID-19 product. Refer to the ID NOW COVID-19 Product Insert for instructions for use. Contents: 12 Positive Control Swabs, 12 Negative Control Swabs
Alere Scarborough, Inc.
190-080
Not in Commercial Distribution

  • 10811877011276 ()


  • SARS-CoV-2 nucleic acid IVD, control
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)
Platelia SARS-CoV-2 Total Ab
BIO-RAD
12015253
In Commercial Distribution

  • 03610522220526 ()

  • 480 tests
12015253

  • SARS-CoV-2 total antibody IVD, kit, enzyme immunoassay (EIA)
Platelia SARS-CoV-2 Total Ab
BIO-RAD
12015289
In Commercial Distribution

  • 03610522220519 ()

  • 96 tests
12015289

  • SARS-CoV-2 total antibody IVD, kit, enzyme immunoassay (EIA)
Western Blot Trays & Lids 8/pkg
Bio-RAD Laboratories, Inc.
12000085
In Commercial Distribution

  • 03610520505304 ()

  • 8 Pkg
12000085

  • HIV1 antibody IVD, kit, immunoblot
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
ARVA Lite Explorer
Adventure Ready Brands
1
In Commercial Distribution

  • 03700507909703 ()
2099-1000

  • First aid kit, medicated
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