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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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WatMIND USA
RDB10-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (1 Test/Box)
In Commercial Distribution

  • 10810172700090 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
No Description
WatMIND USA
RDB6-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)
In Commercial Distribution

  • 10810172700083 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
The BinaxNOW COVID-19 Ag Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals who are suspected of COVID-19 by their healthcare provider.
Alere Scarborough, Inc.
195-000
In Commercial Distribution

  • 10811877011290 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
No Description
PHASE SCIENTIFIC INTERNATIONAL LIMITED
25-Test
In Commercial Distribution

  • 04897116730985 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
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
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
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
Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25)
ACON LABORATORIES, INC.
L031-125P5
In Commercial Distribution

  • 20682607660470 ()
  • 00682607660476 ()
  • 00682607002306 ()
660476

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5)
ACON LABORATORIES, INC.
L031-125N5
In Commercial Distribution

  • 20682607660289 ()
  • 00682607660285 ()
  • 00682607002306 ()
660285

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2)
ACON LABORATORIES, INC.
L031-125M5
In Commercial Distribution

  • 20682607660272 ()
  • 00682607660278 ()
  • 00682607002306 ()
660278

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