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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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Kisses Mini Internal Fixture Φ3.2/L8.0
Achimhai Medical Corporation
MFX-3208S
In Commercial Distribution

  • 08800024912592 ()
MFX-3208S-A

  • Screw endosteal dental implant, two-piece
Kisses Mini Internal Fixture Φ3.2/L9.5
Achimhai Medical Corporation
MFX-3210S
In Commercial Distribution

  • 08800024912585 ()
MFX-3210S-A

  • Screw endosteal dental implant, two-piece
Kisses Mini Internal Fixture Φ3.2/L14.5
Achimhai Medical Corporation
MFX-3215S
In Commercial Distribution

  • 08800024912554 ()
MFX-3215S-A

  • Screw endosteal dental implant, two-piece
Kisses Mini Internal Fixture Φ3.2/L8.0
Achimhai Medical Corporation
MFX-3208SD
In Commercial Distribution

  • 08800024912547 ()
MFX-3208SD-A

  • Screw endosteal dental implant, two-piece
Kisses Mini Internal Fixture Φ3.2/L9.5
Achimhai Medical Corporation
MFX-3210SD
In Commercial Distribution

  • 08800024912530 ()
MFX-3210SD-A

  • Screw endosteal dental implant, two-piece
Kisses Mini Internal Fixture Φ3.2/L14.5
Achimhai Medical Corporation
MFX-3215SD
In Commercial Distribution

  • 08800024912509 ()
MFX-3215SD-A

  • Screw endosteal dental implant, two-piece
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
In Commercial Distribution



  • Instrument/analyser cleaning agent IVD
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.
LUMINEX CORPORATION
20-011-024
In Commercial Distribution

20-011-024

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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
In Commercial Distribution

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
In Commercial Distribution

20-011-021

  • Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
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