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 Resp-4-Plex AMP Kit
ABBOTT MOLECULAR INC.
09N79-096
In Commercial Distribution

  • 00884999049390 ()
09N79-096

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Alinity m Resp-4-Plex Application Specification File
ABBOTT MOLECULAR INC.
09N79-03A
In Commercial Distribution

  • 00884999049383 ()
09N79-03A

  • Laboratory instrument/analyser application software IVD
Alinity m Resp-4-Plex CTRL Kit
ABBOTT MOLECULAR INC.
09N79-085
In Commercial Distribution

  • 00884999049376 ()
09N79-085

  • Multiple-genus respiratory virus nucleic acid IVD, control
Alinity m Resp 4 Plex AMP Kit
ABBOTT MOLECULAR INC.
09N79-095
In Commercial Distribution

  • 00884999049369 ()
09N79-095

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Alinity m Bottle for Ethanol Use
ABBOTT MOLECULAR INC.
09N20-012
In Commercial Distribution

  • 00884999049314 ()
09N20-012

  • Assay container IVD, single-use
Alinity m SARS-CoV-2 AMP Kit
ABBOTT MOLECULAR INC.
09N78-095
In Commercial Distribution

  • 00884999049222 ()
09N78-095

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Alinity m SARS-CoV-2 CTRL Kit
ABBOTT MOLECULAR INC.
09N78-085
In Commercial Distribution

  • 00884999049208 ()
09N78-085

  • SARS-CoV-2 nucleic acid IVD, control
Alinity m SARS-CoV-2 Application Specification File
ABBOTT MOLECULAR INC.
09N78-03A
In Commercial Distribution

  • 00884999049185 ()
09N78-03A

  • Laboratory instrument/analyser application software IVD
No Description
ABBOTT MOLECULAR INC.
09N19-012
In Commercial Distribution

  • 30884999050410 ()
  • 20884999050413 ()
  • 00884999048898 ()
09N19-012

  • General-purpose absorbent tip applicator/swab, single-use
  • General specimen container IVD, no additive/medium
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 STI Application Specification File
ABBOTT MOLECULAR INC.
09N17-03A
In Commercial Distribution

  • 00884999048669 ()
09N17-03A

  • Laboratory instrument/analyser application software IVD
Alinity m HCV Application Specification File
ABBOTT MOLECULAR INC.
08N50-03A
In Commercial Distribution

  • 00884999048652 ()
08N50-03A

  • 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 HIV-1 Application Specification File
ABBOTT MOLECULAR INC.
08N45-03A
In Commercial Distribution

  • 00884999048638 ()
08N45-03A

  • 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 STI CTRL Kit
ABBOTT MOLECULAR INC.
09N17-085
In Commercial Distribution

  • 00884999048607 ()
09N17-085

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
Alinity m STI AMP Kit
ABBOTT MOLECULAR INC.
09N17-095
In Commercial Distribution

  • 00884999048591 ()
09N17-095

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Alinity m IRU Waste Container
ABBOTT MOLECULAR INC.
09N26-020
In Commercial Distribution

  • 00884999048171 ()
09N26-020

  • Laboratory waste receptacle IVD
Alinity m Sample Rack Holder
ABBOTT MOLECULAR INC.
09N26-019
In Commercial Distribution

  • 00884999048096 ()
09N26-019

  • Instrument/analyser specimen/reagent container carrier IVD
Alinity m System
ABBOTT MOLECULAR INC.
08N53-002
In Commercial Distribution

  • 00884999048034 ()
08N53-002

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Alinity m Diluent Solution Kit
ABBOTT MOLECULAR INC.
09N20-003
In Commercial Distribution

  • 20884999047901 ()
  • 00884999047907 ()
09N20-003

  • Molecular grade buffered sample diluent IVD
Alinity m Specimen Dilution Kit I
ABBOTT MOLECULAR INC.
09N50-001
In Commercial Distribution

  • 00884999047884 ()
09N50-001

  • Molecular grade buffered sample diluent IVD
Alinity m Lysis Solution
ABBOTT MOLECULAR INC.
09N20-001
In Commercial Distribution

  • 00884999047877 ()
09N20-001

  • Molecular grade lysis reagent IVD
Alinity m Integrated Reaction Unit (IRU)
ABBOTT MOLECULAR INC.
09N26-010
In Commercial Distribution

  • 20884999047864 ()
  • 00884999047860 ()
09N26-010

  • Pipette tip
Alinity m Pipette Tips, 1000uL
ABBOTT MOLECULAR INC.
09N26-002
In Commercial Distribution

  • 20884999047857 ()
  • 00884999047853 ()
09N26-002

  • Pipette tip
Allinity m Pipette Tips, 50uL
ABBOTT MOLECULAR INC.
09N26-001
In Commercial Distribution

  • 20884999047840 ()
  • 00884999047846 ()
09N26-001

  • Pipette tip
Alinity m HCV CTRL Kit
ABBOTT MOLECULAR INC.
08N50-085
In Commercial Distribution

  • 00884999047839 ()
08N50-085

  • Hepatitis C virus nucleic acid IVD, control
Alinity m HCV CAL Kit
ABBOTT MOLECULAR INC.
08N50-075
In Commercial Distribution

  • 00884999047822 ()
08N50-075

  • Hepatitis C virus nucleic acid IVD, calibrator
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 HIV-1 CTRL Kit
ABBOTT MOLECULAR INC.
08N45-085
In Commercial Distribution

  • 00884999047785 ()
08N45-085

  • HIV1 nucleic acid IVD, control
Alinity m HIV-1 CAL Kit
ABBOTT MOLECULAR INC.
08N45-075
In Commercial Distribution

  • 00884999047778 ()
08N45-075

  • HIV1 nucleic acid IVD, calibrator
Alinity m HCV AMP Kit
ABBOTT MOLECULAR INC.
08N50-095
In Commercial Distribution

  • 00884999047761 ()
08N50-095

  • Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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)
Alinity m HIV-1 AMP Kit
ABBOTT MOLECULAR INC.
08N45-095
In Commercial Distribution

  • 00884999047730 ()
08N45-095

  • HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)
Alinity m Vapor Barrier Solution
ABBOTT MOLECULAR INC.
09N20-004
In Commercial Distribution

  • 00884999047716 ()
09N20-004

  • Molecular grade procedure oil IVD
Alinity m Ethanol Solution
ABBOTT MOLECULAR INC.
09N20-002
In Commercial Distribution

  • 00884999047693 ()
09N20-002

  • Molecular grade alcohol IVD
Alinity m Sample Prep Kit 1
ABBOTT MOLECULAR INC.
09N18-001
In Commercial Distribution

  • 00884999047686 ()
09N18-001

  • Nucleic acid extraction/isolation kit IVD
Alinity m Sample Prep Kit 2
ABBOTT MOLECULAR INC.
09N12-001
In Commercial Distribution

  • 00884999047679 ()
09N12-001

  • Nucleic acid extraction/isolation kit IVD
Alinity m CO-RE Tip Sleeve
ABBOTT MOLECULAR INC.
09N26-004
In Commercial Distribution

  • 00884999047501 ()
09N26-004

  • Pipette tip ejection sleeve
Alinity m Pipette Tip Adapters
ABBOTT MOLECULAR INC.
09N26-003
In Commercial Distribution

  • 00884999047488 ()
09N26-003

  • Pipette tip adaptor
Alinity m Universal Sample Rack
ABBOTT MOLECULAR INC.
09N26-016
In Commercial Distribution

  • 00884999047464 ()
09N26-016

  • Test tube rack
Alinity m Handheld Barcode Scanner
ABBOTT MOLECULAR INC.
09N26-015
In Commercial Distribution

  • 00884999047457 ()
09N26-015

  • Barcode reader
Alinity m Assay Tray Carrier
ABBOTT MOLECULAR INC.
09N26-014
In Commercial Distribution

  • 00884999047440 ()
09N26-014

  • Instrument/analyser specimen/reagent container carrier IVD
Alinity m Waste Bottle
ABBOTT MOLECULAR INC.
09N26-013
In Commercial Distribution

  • 00884999047433 ()
09N26-013

  • Laboratory waste receptacle IVD
Alinity m Waste Box
ABBOTT MOLECULAR INC.
09N26-012
In Commercial Distribution

  • 00884999047426 ()
09N26-012

  • Sharps container
Large
Advanced Bionics, LLC
CI-5837-300
In Commercial Distribution

  • 00840094499997 ()


  • Cochlear implant/auditory brainstem implant sound processor speaker
Medium
Advanced Bionics, LLC
CI-5837-200
In Commercial Distribution

  • 00840094499867 ()


  • Cochlear implant/auditory brainstem implant sound processor speaker
Small
Advanced Bionics, LLC
CI-5837-100
In Commercial Distribution

  • 00840094499850 ()


  • Cochlear implant/auditory brainstem implant sound processor speaker
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