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The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
LUMINEX CORPORATION
20-011-022
20-011-022
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
The Verigene® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) performed using the sample-to-result Verigene® System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers.
LUMINEX CORPORATION
20-011-021
20-011-021
- Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
LUMINEX CORPORATION
20-011-023
20-011-023
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
No Description
Rti Surgical, Inc.
002590
In Commercial Distribution
- 10885862094100 ()
602-05-90
- Bone matrix implant, human-derived
No Description
Rti Surgical, Inc.
002575
In Commercial Distribution
- 10885862094094 ()
602-05-75
- Bone matrix implant, human-derived
No Description
Rti Surgical, Inc.
002529
In Commercial Distribution
- 10885862093226 ()
600-05-90
- Bone matrix implant, human-derived
No Description
Rti Surgical, Inc.
002545
In Commercial Distribution
- 10885862093219 ()
600-05-45
- Bone matrix implant, human-derived
No Description
Rti Surgical, Inc.
002530
In Commercial Distribution
- 10885862093202 ()
600-03-30
- Bone matrix implant, human-derived
No Description
Rti Surgical, Inc.
002523
In Commercial Distribution
- 10885862093196 ()
600-03-20
- Bone matrix implant, human-derived
The Aptiva System Cleaning Solution Kit is for use on the Aptiva Multi-Analyte Instrument to clean the instrument
Optical Module (OM) and flush the system.
INOVA DIAGNOSTICS, INC.
AC1003
- Instrument/analyser cleaning agent IVD