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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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Antistreptolysin-O Reagent (ASO- 2 x 100)
Beckman Coulter, Inc.
469165
In Commercial Distribution

  • 15099590232054 ()
469165

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
IMMAGE Immunochemistry Systems ASO Anti-Streptolysin Reagent
Beckman Coulter, Inc.
447620
In Commercial Distribution

  • 15099590221188 ()
447620

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
ASO
Beckman Coulter, Inc.
OSR6194
In Commercial Distribution

  • 15099590010904 ()


  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
FCP INCUS WIRE CLOSURE MCGEE
Bausch & Lomb Incorporated
N1685 D 1
In Commercial Distribution

  • 00757770411610 ()
N1685 D 1

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, kit, nephelometry/turbidimetry
No Description
SA SCIENTIFIC, LTD.
ST-501
In Commercial Distribution

  • 00780311000882 ()


  • Streptococcus pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
The SAS™ StrepAlert is a rapid visual test for the presumptive qualitative detection of Group A streptococcal antigen from throat swab specimens. The test is for professional use only.
SA SCIENTIFIC, LTD.
611530
In Commercial Distribution

  • 00780311000448 ()


  • Streptococcus pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
THE BINDING SITE GROUP LIMITED
NK626.T.A
In Commercial Distribution

  • 05051700017008 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
NK625.T.A
In Commercial Distribution

  • 05051700016995 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen Test Kit, 25 tests
Lumos Diagnostics, Inc.
CP0031
In Commercial Distribution

  • 00850056728706 ()
CP0031

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. The Nano-Check™ Influenza+COVID-19 Dual Test is only for in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been cleared or approved.
NANO-DITECH CORPORATION
MD8151E
In Commercial Distribution

  • 10895160002844 ()
  • 00895160002847 ()


  • Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical
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