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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Alinity m HR HPV Application Specification File
ABBOTT MOLECULAR INC.
09N15-03A
In Commercial Distribution

  • 00884999048676 ()
09N15-03A

  • Laboratory instrument/analyser application software IVD
Alinity m HBV Application Specification File
ABBOTT MOLECULAR INC.
08N47-03A
In Commercial Distribution

  • 00884999048645 ()
08N47-03A

  • Laboratory instrument/analyser application software IVD
Alinity m HR HPV CTRL Kit
ABBOTT MOLECULAR INC.
09N15-085
In Commercial Distribution

  • 00884999048621 ()
09N15-085

  • Human papillomavirus (HPV) high-risk strain nucleic acid IVD, control
Alinity m HR HPV AMP Kit
ABBOTT MOLECULAR INC.
09N15-095
In Commercial Distribution

  • 00884999048614 ()
09N15-095

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
Alinity m HBV CTRL Kit
ABBOTT MOLECULAR INC.
08N47-085
In Commercial Distribution

  • 00884999047815 ()
08N47-085

  • Hepatitis B virus nucleic acid IVD, control
Alinity m HBV CAL Kit
ABBOTT MOLECULAR INC.
08N47-075
In Commercial Distribution

  • 00884999047808 ()
08N47-075

  • Hepatitis B virus nucleic acid IVD, calibrator
Alinity m HBV AMP Kit
ABBOTT MOLECULAR INC.
08N47-095
In Commercial Distribution

  • 00884999047754 ()
08N47-095

  • Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Medium Precious Pink
Advanced Bionics AG
CI-5552-250
In Commercial Distribution

  • 07630016879388 ()


  • Secondary battery
Small Chestnut
Advanced Bionics AG
CI-5551-130
In Commercial Distribution

  • 07630016879234 ()


  • Secondary battery
Large
Advanced Bionics, LLC
CI-5837-300
In Commercial Distribution

  • 00840094499997 ()


  • Cochlear implant/auditory brainstem implant sound processor speaker
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