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 MPXV AMP Kit
ABBOTT MOLECULAR INC.
09R06-095
In Commercial Distribution

  • 00884999050792 ()
09R06-095

  • Mpox virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Alinity m MPXV CTRL Kit
ABBOTT MOLECULAR INC.
09R06-085
In Commercial Distribution

  • 00884999050785 ()
09R06-085

  • Mpox virus nucleic acid IVD, reagent
Alinity m MPXV Application Specification File
ABBOTT MOLECULAR INC.
09R06-05A
In Commercial Distribution

  • 00884999050778 ()
09R06-05A

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

  • 00884999050464 ()
09N79-05E

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

  • 00884999050457 ()
09N78-03F

  • Laboratory instrument/analyser application software IVD
Abbott Bulk Universal Collection Kit
ABBOTT MOLECULAR INC.
09N92-010
In Commercial Distribution

  • 00884999050280 ()
09N92-010

  • General specimen collection kit IVD, clinical
Alinity m Resp-4-Plex Application Specification File
ABBOTT MOLECULAR INC.
09N79-05D
In Commercial Distribution

  • 00884999050242 ()
09N79-05D

  • Laboratory instrument/analyser application software IVD
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
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