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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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BinaxNOW COVID-19 Antigen Self Test - 00811877011446

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
Alere Scarborough, Inc.
195-261
In Commercial Distribution

  • 00811877011446 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

BinaxNOW COVID-19 Antigen Self Test - 00811877011415

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
Alere Scarborough, Inc.
195-260
In Commercial Distribution

  • 00811877011415 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

BinaxNOW COVID-19 Ag Card Home Test - 00811877011330

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens
Alere Scarborough, Inc.
195-100
In Commercial Distribution

  • 00811877011330 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Advin COVID-19 Antigen Test @Home - B115ABCASS5CANAO1

No Description
ADVIN BIOTECH, INC.
ABCass(5)-CAN-AO
In Commercial Distribution

  • B115ABCASS5CANAO1 ()
  • B115ABCASS5CANAO0 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Advin COVID-19 Antigen Test @Home - B115ABCASS1CANAO1

No Description
ADVIN BIOTECH, INC.
ABCass(1)-CAN-AO
In Commercial Distribution

  • B115ABCASS1CANAO1 ()
  • B115ABCASS1CANAO2 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Speedy Swab Rapid COVID-19 & FLU A+B (4 Tests/Box) - 00810172700079

No Description
WatMIND USA
Speedy Swab Rapid COVID-19 & FLU A+B (4 Tests/Box)
In Commercial Distribution

  • 00810172700079 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Speedy Swab Rapid COVID-19 & FLU A&B Self-Test - 50810172700098

No Description
WatMIND USA
CARTON-1V500-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (1 Test/Box)
In Commercial Distribution

  • 50810172700098 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Speedy Swab Rapid COVID-19 & FLU A&B Self-Test - 50810172700081

No Description
WatMIND USA
CARTON-2V300-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)
In Commercial Distribution

  • 50810172700081 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

CARTON-RDB1V10-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Test (1 Test/Box) - 40810172700091

No Description
WatMIND USA
CARTON-RDB1V10-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Test (1 Test/Box)
In Commercial Distribution

  • 40810172700091 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Genabio COVID-19 Rapid Self-Test Kit - 00810143620184

No Description
Genabio Diagnostics Inc.
N/A
In Commercial Distribution

  • 00810143620184 ()
  • 81014362018400 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
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