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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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B&B SKIN HOOK; 5''(12.5CM)
BLACK & BLACK SURGICAL, INC.
B61527
In Commercial Distribution

  • 00840329806958 ()
B61527

  • Soft-tissue surgical hook, reusable
OPERATING SCISSORS CVD B/B 6.5
SKLAR CORPORATION
21-300
In Commercial Distribution

  • 40649111036164 ()
  • 00649111036166 ()


  • 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
No Description
REMEL EUROPE LIMITED
R30164501
In Commercial Distribution

  • 05056080501567 ()


  • Multiple meningitis-associated bacteria antigen IVD, reagent
The Revogene® C. difficile assay performed on the Revogene instrument is a qualitative in vitro diagnostic test that utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The Revogene C. difficile assay is intended to aid in the diagnosis of CDI.
Meridian Bioscience Canada Inc
410300
Not in Commercial Distribution

  • 00628055344124 ()
410300

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
The GenePOC™ CDiff assay performed on the revogene™ instrument is a qualitative in vitro diagnostic test that utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The GenePOC CDiff assay is intended to aid in the diagnosis of CDI.
GenePoc Inc
132994
Not in Commercial Distribution

  • 00628055344025 ()
132994

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
QIAGEN GmbH
1
Not in Commercial Distribution

  • 04053228004646 ()
4572346

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
BD MAX™ Cdiff (US)
BECTON, DICKINSON AND COMPANY
443418
In Commercial Distribution

  • 00382904434182 ()
443418

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
The ARIES® C. difficile Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Clostridium difficile (C. difficile) nucleic acid in unformed (liquid or soft) stool specimens obtained from patients suspected of having Clostridium difficile infection (CDI).
LUMINEX CORPORATION
50-10018
Not in Commercial Distribution

  • 00840487100059 ()


  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
The Revogene C. difficile assay performed on the Revogene instrument is a qualitative in vitro diagnostic test that utilizes automated sample processing and real time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection. The Revogene C. difficile assay is intended to aid in the diagnosis of CDI.
MERIDIAN BIOSCIENCE, INC.
410300
In Commercial Distribution

  • 00840733102349 ()
401300

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