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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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Candida auris Primer Set
Fort Worth Diagnostics, LLC
CAUR001
In Commercial Distribution

  • 00850051429059 ()
CAUR001

  • Assay development analyte-specific reagent IVD
Ehrlichia Primer Set
Fort Worth Diagnostics, LLC
EHR001
In Commercial Distribution

  • 00850051429042 ()
EHR001

  • Assay development analyte-specific reagent IVD
Borrelia Primer Set
Fort Worth Diagnostics, LLC
BOR001
In Commercial Distribution

  • 00850051429035 ()
BOR001

  • Assay development analyte-specific reagent IVD
Anaplasma Primer Set
Fort Worth Diagnostics, LLC
ANA001
In Commercial Distribution

  • 00850051429028 ()
ANA001

  • Assay development analyte-specific reagent IVD
Babesia Primer Set
Fort Worth Diagnostics, LLC
BAB001
In Commercial Distribution

  • 00850051429004 ()
BAB001

  • Assay development analyte-specific reagent IVD
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).
NANOSPHERE, INC.
20-011-022
Not in Commercial Distribution

  • 00857573006317 ()


  • 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.
NANOSPHERE, INC.
20-011-021
Not in Commercial Distribution

  • 00857573006300 ()


  • Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection.
NANOSPHERE, INC.
20-011-024
Not in Commercial Distribution

  • 00857573006324 ()


  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection.
NANOSPHERE, INC.
20-011-020
Not in Commercial Distribution

  • 00857573006294 ()


  • Multiple-genus respiratory virus 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.
NANOSPHERE, INC.
20-011-023
Not in Commercial Distribution

  • 00857573006089 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
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