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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)
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 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)
No Description
DIASORIN MOLECULAR LLC
MOL5290
In Commercial Distribution
- 20816101025613 ()
MOL5290
- Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
DIASORIN MOLECULAR LLC
MOL2960
In Commercial Distribution
- 20816101025606 ()
MOL2960
- Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
DIASORIN MOLECULAR LLC
MOL2950
In Commercial Distribution
- 20816101025590 ()
MOL2950
- Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
DIASORIN MOLECULAR LLC
MOL2975
In Commercial Distribution
- 20816101025583 ()
MOL2975
- 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)