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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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ID NOW™ COVID-19 Control Swab Kit - 10811877011276

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

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

Boson - Rapid SARS-CoV-2 Antigen Test Card - 2 Tests/Kit - 06921963715296

Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
Xiamen Boson Biotech Co., Ltd.
1N40C5-2-US
In Commercial Distribution

  • 06921963715258 ()
  • 06921963715296 ()


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

Boson - Rapid SARS-CoV-2 Antigen Test Card - 4 Tests/Kit - 06921963712950

Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
Xiamen Boson Biotech Co., Ltd.
1N40C5-4-US
In Commercial Distribution

  • 06921963715258 ()
  • 06921963712950 ()
  • 16921963712957 ()


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

Boson - Rapid SARS-CoV-2 Antigen Test Card - 10 Tests/Kit - 06921963712943

Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
Xiamen Boson Biotech Co., Ltd.
1N40C5-10-US
In Commercial Distribution

  • 06921963715258 ()
  • 06921963712943 ()


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

Boson - Rapid SARS-CoV-2 Antigen Test Card - 40 Tests/Kit - 06921963712936

Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
Xiamen Boson Biotech Co., Ltd.
1N40C5-40-US
In Commercial Distribution

  • 06921963715258 ()
  • 06921963712936 ()


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

Boson - Rapid SARS-CoV-2 Antigen Test Card - 8 Tests/Kit - 06921963712929

Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
Xiamen Boson Biotech Co., Ltd.
1N40C5-8-US
In Commercial Distribution

  • 06921963715258 ()
  • 06921963712929 ()


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

Boson - Rapid SARS-CoV-2 Antigen Test Card - 20 Tests/Kit - 06921963712523

Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
Xiamen Boson Biotech Co., Ltd.
1N40C5-20-US
In Commercial Distribution

  • 06921963715258 ()
  • 06921963712523 ()


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

Boson - Rapid SARS-CoV-2 Antigen Test Card - 5 Tests/Kit - 06921963712516

Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
Xiamen Boson Biotech Co., Ltd.
1N40C5-5-US
In Commercial Distribution

  • 06921963715258 ()
  • 06921963712516 ()


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

Boson - Rapid SARS-CoV-2 Antigen Test Card - 2 Tests/Kit - 06921963712509

Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
Xiamen Boson Biotech Co., Ltd.
1N40C5-2-US
In Commercial Distribution

  • 06921963712509 ()
  • 06921963715258 ()


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