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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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Alinity m SARS-CoV-2 Application Specification
ABBOTT MOLECULAR INC.
09N78-03E
In Commercial Distribution

  • 00884999050211 ()
09N78-03E

  • Laboratory instrument/analyser application software IVD
Alinity m SARS COV-2 Application Specification File
ABBOTT MOLECULAR INC.
09N78-03D
In Commercial Distribution

  • 00884999050136 ()
09N78-03D

  • Laboratory instrument/analyser application software IVD
No Description
ABBOTT MOLECULAR INC.
09N79-05C
In Commercial Distribution

  • 00884999050020 ()
09N79-05C

  • Laboratory instrument/analyser application software IVD
Alinity m Resp-4-Plex Application Specification File
ABBOTT MOLECULAR INC.
09N79-05A
In Commercial Distribution

  • 00884999049413 ()
09N79-05A

  • Laboratory instrument/analyser application software IVD
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
Abbott RealTime SARS-CoV-2 Application CD-ROM
ABBOTT MOLECULAR INC.
09N77-010
In Commercial Distribution

  • 00884999049055 ()
09N77-010

  • Laboratory instrument/analyser application software IVD
Abbott RealTime ZIKA Application CD-ROM
ABBOTT MOLECULAR INC.
09N27-002
In Commercial Distribution

  • 00884999047068 ()
09N27-002

  • Laboratory instrument/analyser application software IVD
No Description
STRADIS MEDICAL, LLC
689-441
Not in Commercial Distribution

  • M7526894410 ()


  • General surgical procedure kit, non-medicated, single-use
Tissue Processing Kit
STRADIS MEDICAL, LLC
689-432
Not in Commercial Distribution

  • M7526894320 ()


  • General surgical procedure kit, non-medicated, single-use
No Description
STRADIS MEDICAL, LLC
689-427
Not in Commercial Distribution

  • M7526894270 ()
  • M7526894271 ()


  • General surgical procedure kit, non-medicated, single-use
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