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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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YASARGIL SCISS STR, B/B 7.75"
SKLAR CORPORATION
98-2104
In Commercial Distribution

  • 10649111001116 ()


  • General-purpose surgical scissors, reusable
YASARGIL SCISS STR, B/B 6.25"
SKLAR CORPORATION
98-2102
In Commercial Distribution

  • 10649111000966 ()


  • General-purpose surgical scissors, reusable
OP SCISS STR B/B 5.5"
SKLAR CORPORATION
15-1055
In Commercial Distribution

  • 10649111097683 ()


  • General-purpose surgical scissors, reusable
Operating Scissor B/B 5.5"STR
K.T.SURGICO
2025
Not in Commercial Distribution

  • SCISSORBB01 ()
  • KTS0810214 ()
  • TMS1530014 ()
KTS0810214

  • General-purpose surgical scissors, single-use
OPERATING SCISSORS CVD B/B 6.5
SKLAR CORPORATION
21-300
In Commercial Distribution

  • 40649111036164 ()
  • 00649111036166 ()


  • General-purpose surgical scissors, reusable
Rapid Response Respiratory Syncytial Virus Test Cassette - 30 tests/ kit are for the qualitative detection of Respiratory Syncytial Virus Antigen in Nasopharyngeal specimens.
BTNX Inc
RSV-19C30
In Commercial Distribution

  • 00722066001974 ()
  • 00722066004265 ()
RSV-19C30

  • Influenza virus/respiratory syncytial virus (RSV) antigen IVD, kit, immunochromatographic test (ICT), rapid
The Alethia™ C. difficile DNA amplification assay, performed on the Alethia™ Instrument, is a qualitative in vitro diagnostic test for the direct detection of toxigenic C. difficile in human stool specimens from pediatric and adult patients suspected of having Clostridium difficile-associated disease (CDAD). The Alethia™ C. difficile assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect the pathogenicity locus (PaLoc) of toxigenic Clostridium difficile. The Clostridium difficile PaLoc is a gene segment present in all known toxigenic C. difficile strains. The C. difficile PaLoc codes for both the Toxin A gene (tcdA) and the Toxin B gene (tcdB), has conserved border regions, and is found at the same site on the C. difficile genome for all toxigenic strains. The Alethia™ C. difficile assay detects the PaLoc by targeting a partial DNA fragment on the Toxin A gene. The tcdA target region was selected as an intact region remaining in all known A+B+ and A-B+ toxinotypes.
MERIDIAN BIOSCIENCE, INC.
480050
In Commercial Distribution

  • 00840733102172 ()
480050

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
The illumigene C. difficile DNA amplification assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the direct detection of toxigenic C. difficile in human stool specimens from pediatric and adult patients suspected of having Clostridium difficile-associated disease (CDAD). The illumigene C. difficile assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect the pathogenicity locus (PaLoc) of toxigenic Clostridium difficile. The Clostridium difficile PaLoc is a gene segment present in all known toxigenic C. difficile strains. The C. difficile PaLoc codes for both the Toxin A gene (tcdA) and the Toxin B gene (tcdB), has conserved border regions, and is found at the same site on the C. difficile genome for all toxigenic strains. The illumigene C. difficile assay detects the PaLoc by targeting a partial DNA fragment on the Toxin A gene. The tcdA target region was selected as an intact region remaining in all known A+B+ and A-B+ toxinotypes.
MERIDIAN BIOSCIENCE, INC.
280050
Not in Commercial Distribution

  • 00840733101168 ()
280050

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert C. difficile test; 120 test kit
CEPHEID
GXCDIFFICILE-120
In Commercial Distribution

  • 07332940000059 ()
GXCDIFFICILE-120

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert C. difficile/Epi kit; 120 test kit
CEPHEID
GXCDIFF/EPI-120
In Commercial Distribution

  • 07332940000042 ()
GXCDIFF/EPI-120

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
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