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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 Class Implantable

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ABBOTT PRISM NEXT MAIN INSTRUMENT SIX CHANNEL
ABBOTT LABORATORIES
6A36-34
Not in Commercial Distribution

  • 00380740008574 ()
06A3634

  • Chemiluminescent immunoassay analyser IVD
ABBOTT PRISM NEXT MAIN INSTRUMENT SIX CHANNEL
ABBOTT LABORATORIES
6A36-11
Not in Commercial Distribution

  • 00380740008420 ()
06A3611

  • Chemiluminescent immunoassay analyser IVD
ABBOTT PRISM Pipette Tips
ABBOTT LABORATORIES
5A07-10
Not in Commercial Distribution

  • 00380740007911 ()
  • 00380740138325 ()
05A0710

  • Chemiluminescent immunoassay analyser IVD
ABBOTT PRISM Reaction Trays
ABBOTT LABORATORIES
5A07-01
Not in Commercial Distribution

  • 00380740007904 ()
  • 00380740132361 ()
05A0701

  • Chemiluminescent immunoassay analyser IVD
Alinity s System
ABBOTT LABORATORIES
06P1601
In Commercial Distribution

  • 00380740138479 ()
06P1601

  • Chemiluminescent immunoassay analyser IVD
Alinity s Maintenance Cleaning Kit
ABBOTT LABORATORIES
04R7050
In Commercial Distribution

  • 00380740156817 ()
  • 00380740167776 ()
04R7050

  • Chemiluminescent immunoassay analyser IVD
REAL i-Series
PENUMBRA, INC.
RLE1-A
In Commercial Distribution

  • 00815948024229 ()


  • Mental health/function therapeutic software, virtual reality
  • Mindfulness/behavioural therapy software, non-clinician-consultative
Auto Reader IV
ORTHO-CLINICAL DIAGNOSTICS, INC.
6902093
In Commercial Distribution

  • 10758750007523 ()
6902093

  • Microplate reader IVD, automated/semi-automated
ORTHO VERSEIA™ Pipetter
ORTHO-CLINICAL DIAGNOSTICS, INC.
5561701
In Commercial Distribution

  • 10758750013265 ()
5561701

  • Enzyme immunoassay (EIA) analyser IVD
ORTHO VERSEIA™ Pipetter Workstation - monitor, accessories
ORTHO-CLINICAL DIAGNOSTICS, INC.
6842852B
In Commercial Distribution

  • 10758750011599 ()
6842852B

  • Enzyme immunoassay (EIA) analyser IVD
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