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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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OrtFlx Com McLaughlin 022 U4/5 Rx -7º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-830
In Commercial Distribution

  • 00190730002303 ()


  • Orthodontic bracket, plastic, single-use
OrtFlx Com McLaughlin 018 L1/2 Rx -6º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-741
In Commercial Distribution

  • 00190730001962 ()


  • Orthodontic bracket, plastic, single-use
Avalon Com Roth 018 L1/2 Rx -6° Tor. 0° Ang.(10PK)
ORTHO TECHNOLOGY, INC.
A18-741
Not in Commercial Distribution

  • 00190730000460 ()


  • Orthodontic bracket, plastic, 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 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)
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)
No Description
Vela Operations USA Inc.
00
In Commercial Distribution

  • G491CDF2SPD0 ()
CDF2-SPD

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Vela Operations USA Inc.
01
In Commercial Distribution

  • G491CDF21 ()
  • G491CDF20 ()
300786

  • 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)
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