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CorDx COVID-19 Ag Test
CORETESTS, INC.
CO291-2
In Commercial Distribution
- 10850042559120 ()
- 00850042559123 ()
- 00850042559116 ()
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx COVID-19 Ag Test
CORETESTS, INC.
CO291-10
In Commercial Distribution
- 00850042559093 ()
- 10850042559090 ()
- 00850042559109 ()
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx COVID-19 Ag Test
CORETESTS, INC.
CO291-5
In Commercial Distribution
- 00850042559086 ()
- 10850042559083 ()
- 00850042559109 ()
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx COVID-19 Ag Test
CORETESTS, INC.
CO291-2
In Commercial Distribution
- 00850042559079 ()
- 10850042559076 ()
- 00850042559109 ()
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
The Rapid SARS-CoV-2 Antigen Test Card is a single use rapid lateral flow chromatographic immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 and older, when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized 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.
This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years and older when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals aged 2 years and older 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.
LUMIQUICK DIAGNOSTICS, INC.
1N40C5-1-US-BS
In Commercial Distribution
- 00855636003723 ()
- 00855636003716 ()
- 00855636003730 ()
- 00855636003747 ()
- 00855636003754 ()
- 00855636003761 ()
- 00855636003778 ()
- 00855636003785 ()
1N40C5-1-US-BS
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
No Description
IHEALTH LAB INC.
ICO-3000
In Commercial Distribution
- 10856362005903 ()
- 00856362005906 ()
- 20856362005900 ()
- 30856362005907 ()
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
No Description
IHEALTH LAB INC.
ICO-3000
In Commercial Distribution
- 10856362005897 ()
- 00856362005890 ()
- 20856362005894 ()
- 30856362005891 ()
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.
NANO-DITECH CORPORATION
MD-8147
In Commercial Distribution
- 10895160002868 ()
- 00895160002861 ()
MD-8147 2T
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
An in vitro diagnostic, a time resolved fluorescence lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.
NANO-DITECH CORPORATION
TF-8150
In Commercial Distribution
- 10895160002790 ()
- 00895160002793 ()
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 25 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0001-25
In Commercial Distribution
- 10816862024729 ()
- 00816862024722 ()
- 00816862024715 ()
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing