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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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External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray RP2 and RP2plus assay on the FilmArray 2.0/Torch systems.
Mmqci
v.00
Not in Commercial Distribution

  • 00852720008039 ()
M315

  • Multiple-genus respiratory virus nucleic acid IVD, control
External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray Pneumonia Panel or Pneumonia Panel plus assay on the FilmArray systems.
Mmqci
v.00
In Commercial Distribution

  • 00852720008022 ()
M340

  • Multiple-type respiratory pathogen nucleic acid IVD, control
This independent CF control is intended for in vitro diagnostic use to monitor the entire testing process of diagnostic assays used in the detection of the CFTR gene mutations and variants.
Mmqci
v.02
In Commercial Distribution

  • 00852720008015 ()
G106ac

  • Cystic fibrosis IVD, control
This independent CF control is intended for in vitro diagnostic use to monitor the entire testing process of diagnostic assays used in the detection of the CFTR gene mutations and variants.
Mmqci
v.02
In Commercial Distribution

  • 00852720008008 ()
G106ac-1

  • Cystic fibrosis IVD, control
No Description
Radiobotics ApS
v.1.
In Commercial Distribution

  • 05700002173614 ()


  • X-ray image interpretive software
Aero/Vent Plus Ventilator Kit w/HEPA Filter, For ventilator dependent patients
Medi/Nuclear Corporation, Inc.
AV-400+V
In Commercial Distribution

  • 00857863007246 ()
  • 00857863007062 ()


  • Radioaerosol administration set
iOS version of the Baha Smart App
Cochlear Bone Anchored Solutions AB
V 1.2
In Commercial Distribution

  • 09321502078962 ()
P1646054

  • Audiometric/hearing device software
Android version of the Baha Smart App
Cochlear Bone Anchored Solutions AB
V 1.2
In Commercial Distribution

  • 09321502078955 ()
P1646035

  • Audiometric/hearing device software
VA version of Baha Fitting Software 7
Cochlear Bone Anchored Solutions AB
V 7.0
In Commercial Distribution

  • 09321502075527 ()
P2121915

  • Hearing aid wireless-fitting computer-aided set
No Description
Cochlear Bone Anchored Solutions AB
V 7.0
In Commercial Distribution

  • 09321502075510 ()
P2121898

  • Hearing aid wireless-fitting computer-aided set
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