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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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The COVID-19 total Ab Control LQ is designed to estimate the test and FREND™ COVID-19 total Ab cartridges. COVID-19 total Ab Control LQ is not intended for use as a standard.
NanoEnTek, Inc.
FIC-COALQ
In Commercial Distribution

  • 08809317540917 ()
FIC-COALQ

  • SARS-CoV-2 total antibody IVD, control
ABBOTT PRISM Purge Concentrate
ABBOTT LABORATORIES
7A03-30
Not in Commercial Distribution

  • 00380740050375 ()
07A0330

  • Chemiluminescent immunoassay analyser IVD
ABBOTT PRISM Activator Line Treatment
ABBOTT LABORATORIES
1A75-10
Not in Commercial Distribution

  • 00380740038373 ()
01A7510

  • Wash/cleaning solution IVD, automated/semi-automated system
ABBOTT PRISM Prime/Purge Accessories
ABBOTT LABORATORIES
7A03-01
Not in Commercial Distribution

  • 00380740027056 ()
07A0301

  • Buffered wash solution IVD
ABBOTT PRISM SAMPLE CUPS
ABBOTT LABORATORIES
7B36-01
Not in Commercial Distribution

  • 00380740012403 ()
  • 00380740132378 ()
07B3601

  • Chemiluminescent immunoassay analyser IVD
ABBOTT PRISM Line Cleaner
ABBOTT LABORATORIES
7A03-31
Not in Commercial Distribution

  • 00380740011604 ()
07A0331

  • Wash/cleaning solution IVD, automated/semi-automated system
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
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