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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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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
The illumigene Group A Streptococcus (Group A Strep) assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A beta-hemolytic Streptococcus) in throat swab specimens. The illumigene 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 illumigene 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.
280150
Not in Commercial Distribution

  • 00840733101335 ()
280150

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Status™ COVID-19/Flu A&B Antigen test kit, 25 tests
PRINCETON BIOMEDITECH CORPORATION
BSP-511-25
In Commercial Distribution

  • 10743816001553 ()
BSP-511-25

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Prime NM Implant, 39x27mm x 18mm, 25 Deg
Seaspine Orthopedics Corporation
35-97-1825
In Commercial Distribution

  • 10889981159634 ()

  • N/A
35-97-1825

  • Vertebral body prosthesis
Prime NM Implant, 43x30mm x 18mm, 25 Deg
Seaspine Orthopedics Corporation
35-30-1825
In Commercial Distribution

  • 10889981160128 ()

  • N/A
35-30-1825

  • Vertebral body prosthesis
Prime NM Implant, 43x30mm x 16mm, 25 Deg
Seaspine Orthopedics Corporation
35-30-1625
In Commercial Distribution

  • 10889981159665 ()

  • N/A
35-30-1625

  • Vertebral body prosthesis
Prime NM Implant, 39x30mm x 18mm, 25 Deg
Seaspine Orthopedics Corporation
35-90-1825
In Commercial Distribution

  • 10889981159658 ()

  • N/A
35-90-1825

  • Vertebral body prosthesis
Prime NM Implant, 39x30mm x 16mm, 25 Deg
Seaspine Orthopedics Corporation
35-90-1625
In Commercial Distribution

  • 10889981159641 ()

  • N/A
35-90-1625

  • Vertebral body prosthesis
Prime NM Implant, 39x27mm x 16mm, 25 Deg
Seaspine Orthopedics Corporation
35-97-1625
In Commercial Distribution

  • 10889981159627 ()

  • N/A
35-97-1625

  • Vertebral body prosthesis
Prime NM Implant, 39x27mm x 14mm, 25 Deg
Seaspine Orthopedics Corporation
35-97-1425
In Commercial Distribution

  • 10889981159610 ()

  • N/A
35-97-1425

  • Vertebral body prosthesis
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