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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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Bordetella Pertussis IgG kit is an Enzyme Linked Immunosorbent assay (ELISA) for the qualitative detection of specific IgG antibodies to Bordetella pertussis.
SAVYON DIAGNOSTICS LTD
A2231-01M
In Commercial Distribution

  • 07290016332636 ()
A2231-01M

  • Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
The SeroELISAChlamydia IgA kit is intended for the determination of specific IgA antibodies to Chlamydia in a single human serum sample by an Enzyme-Linked Immunosorbent Assay (ELISA). For In Vitro Diagnostic Use.
SAVYON DIAGNOSTICS LTD
A113-01
In Commercial Distribution

  • 07290001913161 ()


  • Chlamydia pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
SA SCIENTIFIC, LTD.
ST-501
In Commercial Distribution

  • 00780311000882 ()


  • Streptococcus pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
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
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)
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 Alethia™ Group A Streptococcus (Group A Strep) assay, performed on the Alethia™ Instrument, is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A beta-hemolytic Streptococcus) in throat swab specimens. The Alethia™ Group A Strep assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome. Results from the Alethia™ Group A Strep assay can be used as an aid in the diagnosis of Group A Streptococcal pharyngitis. The assay is not intended to monitor treatment for Group A Streptococcus infections.
MERIDIAN BIOSCIENCE, INC.
480150
In Commercial Distribution

  • 00840733102264 ()
480150

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Alethia™ Group A Streptococcus (Group A Strep) External Control Kit contains Positive Reagent for use with the Alethia™ Group A Streptococcus DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the Alethia™ Sample Preparation Apparatus II/Negative Control III reagent provided with the Group A Strep Kit as part of routine Quality Control Testing. External controls are used as part of a routine quality control program.
MERIDIAN BIOSCIENCE, INC.
479910
In Commercial Distribution

  • 00840733102127 ()
479910

  • Streptococcus mutans group antigen IVD, calibrator
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