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Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. For use under an emergency use authorization (EUA) only.
Genbody Inc.
COVAGHT2-U-5
In Commercial Distribution
- 08800076700758 ()
- 08800076700727 ()
COVAGHT2-U-05
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. For use under an emergency use authorization (EUA) only.
Genbody Inc.
COVAGHT2-U-25
In Commercial Distribution
- 08800076700765 ()
- 08800076700598 ()
COVAGHT2-U-25
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. For use under an emergency use authorization (EUA) only.
Genbody Inc.
COVAGHT2-U-2
In Commercial Distribution
- 08800076700741 ()
- 08800076700222 ()
COVAGHT2-U-02
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
No Description
SOBERLINK HEALTHCARE LLC
SOBERLINK CELLULAR CATM
In Commercial Distribution
- B90110 ()
- Alcohol breath analyser
No Description
SOBERLINK HEALTHCARE LLC
SOBERLINK CONNECT ST - 08
In Commercial Distribution
- B90108 ()
- Alcohol breath analyser
No Description
SOBERLINK HEALTHCARE LLC
SOBERLINK LTE - 06
In Commercial Distribution
- B90106 ()
- Alcohol breath analyser
No Description
SOBERLINK HEALTHCARE LLC
SOBERLINK GSM1 REFURB - 05
Not in Commercial Distribution
- B90105 ()
- Alcohol breath analyser
No Description
SOBERLINK HEALTHCARE LLC
SOBERLINK GSM2 - 02
In Commercial Distribution
- B90102 ()
- Alcohol breath analyser
No Description
SOBERLINK HEALTHCARE LLC
SOBERLINK Connect - 01
In Commercial Distribution
- B90101 ()
- Alcohol breath analyser
Disposable breath alcohol test
Alcopro Inc.
CP08
In Commercial Distribution
- G354CCP084104 ()
- G354CCP084103 ()
- G354CCP084100 ()
CCP08410
- Alcohol breath analyser