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MONOBIND, INC.
13225-300
In Commercial Distribution
- 00816870023953 ()
- Width: 7.75 Inch
13225-300A
- Interleukin-6 receptor (IL-6r) IVD, kit, enzyme immunoassay (EIA)
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Extraction Buffer
ORTHO-CLINICAL DIAGNOSTICS, INC.
6199944
In Commercial Distribution
- 10758750033577 ()
6199944
- Clinical specimen extraction buffer IVD
Status™ COVID-19 Antigen for Home Use, 25 Test Kit
PRINCETON BIOMEDITECH CORPORATION
BSP-512-25-00
In Commercial Distribution
- 10743816001645 ()
BSP-512-025-00
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Status™ COVID-19 Antigen Rapid Test for Home Use, 1 Test Kit
PRINCETON BIOMEDITECH CORPORATION
BSP-512-01-00
In Commercial Distribution
- 10743816001621 ()
BSP-512-01-00
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 anterior nasal (AN) swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset. For use under an emergency use authorization (EUA) only.
Genbody Inc.
COVAG025-NU-1
In Commercial Distribution
- 08800076700772 ()
- 08800076700789 ()
COVAG025-NU-1
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
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-1
In Commercial Distribution
- 08800076700734 ()
COVAGHT2-U-01
- 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-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
Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 anterior nasal (AN) swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset. For use under an emergency use authorization (EUA) only.
Genbody Inc.
COVAG025-NU
In Commercial Distribution
- 08800076700499 ()
- 08800076700482 ()
COVAG025-NU
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 in direct nasopharyngeal swab (NP) specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset. Emergency use of this test is limited to authorized laboratories.
Genbody Inc.
COVAG025-U
In Commercial Distribution
- 08800076700437 ()
- 08800076700475 ()
COVAG025-U
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical