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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Small Chestnut
Advanced Bionics AG
CI-5551-130
In Commercial Distribution

  • 07630016879234 ()


  • Secondary battery
Large
Advanced Bionics, LLC
CI-5837-300
In Commercial Distribution

  • 00840094499997 ()


  • Cochlear implant/auditory brainstem implant sound processor speaker
Medium
Advanced Bionics, LLC
CI-5837-200
In Commercial Distribution

  • 00840094499867 ()


  • Cochlear implant/auditory brainstem implant sound processor speaker
Small
Advanced Bionics, LLC
CI-5837-100
In Commercial Distribution

  • 00840094499850 ()


  • Cochlear implant/auditory brainstem implant sound processor speaker
Alinity m EBV Application Specification File
ABBOTT MOLECULAR INC.
09N43-05B
In Commercial Distribution

09N43-05B

  • Laboratory instrument/analyser application software IVD
Alinity m STI Application Specification File
ABBOTT MOLECULAR INC.
09N17-03B
In Commercial Distribution

09N17-03B

  • Laboratory instrument/analyser application software IVD
Alinity m CMV Application Specification File
ABBOTT MOLECULAR INC.
09N46-05B
In Commercial Distribution

09N46-05B

  • Laboratory instrument/analyser application software IVD
Alinity m BKV Application Specification File
ABBOTT MOLECULAR INC.
09N85-05A
In Commercial Distribution

  • 00884999050945 ()
09N85-05A

  • Laboratory instrument/analyser application software IVD
Alinity m HCV Application Specification File
ABBOTT MOLECULAR INC.
08N50-03B
In Commercial Distribution

  • 00884999050860 ()
08N50-03B

  • Laboratory instrument/analyser application software IVD
Alinity m HIV-1 Application Specification File
ABBOTT MOLECULAR INC.
08N45-03C
In Commercial Distribution

  • 00884999050853 ()
08N45-03C

  • Laboratory instrument/analyser application software IVD
Alinity m HBV Application Specification File
ABBOTT MOLECULAR INC.
08N47-03B
In Commercial Distribution

  • 00884999050808 ()
08N47-03B

  • Laboratory instrument/analyser application software IVD
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 BKV AMP Kit
ABBOTT MOLECULAR INC.
09N85-095
In Commercial Distribution

  • 00884999050709 ()
09N85-095

  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Alinity m BKV CTRL Kit
ABBOTT MOLECULAR INC.
09N85-085
In Commercial Distribution

  • 00884999050686 ()
09N85-085

  • BK virus (BKV) nucleic acid IVD, control
Alinity m BKV CAL Kit
ABBOTT MOLECULAR INC.
09N85-075
In Commercial Distribution

  • 00884999050662 ()
09N85-075

  • BK virus (BKV) nucleic acid IVD, calibrator
Alinity m HSV 1 & 2 / VZV AMP Kit
ABBOTT MOLECULAR INC.
09N61-095
In Commercial Distribution

  • 00884999050594 ()
09N61-095

  • Multiple Human herpesvirus nucleic acid IVD, kit, nucleic acid technique (NAT)
Alinity m HSV 1 & 2 / VZV CTRL Kit
ABBOTT MOLECULAR INC.
09N61-085
In Commercial Distribution

  • 00884999050587 ()
09N61-085

  • Multiple Human herpesvirus nucleic acid IVD, control
Alinity m HSV 1 & 2 / VZV Application Specification File
ABBOTT MOLECULAR INC.
09N61-03A
In Commercial Distribution

  • 00884999050570 ()
09N61-03A

  • 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
Alinity m HIV-1 Application Specification File
ABBOTT MOLECULAR INC.
08N45-03B
In Commercial Distribution

  • 00884999050402 ()
08N45-03B

  • 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
Alinity m CMV Application Specification File
ABBOTT MOLECULAR INC.
09N46-05A
In Commercial Distribution

  • 00884999049956 ()
09N46-05A

  • Laboratory instrument/analyser application software IVD
Alinity m EBV ApplicationSpecification File
ABBOTT MOLECULAR INC.
09N43-05A
In Commercial Distribution

  • 00884999049697 ()
09N43-05A

  • Laboratory instrument/analyser application software IVD
Alinity m CMV AMP Kit
ABBOTT MOLECULAR INC.
09N46-095
In Commercial Distribution

  • 00884999049611 ()
09N46-095

  • Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Alinity m CMV CTRL Kit
ABBOTT MOLECULAR INC.
09N46-085
In Commercial Distribution

  • 00884999049604 ()
09N46-085

  • Cytomegalovirus (CMV) nucleic acid IVD, control
Alinity m CMV CAL Kit
ABBOTT MOLECULAR INC.
09N46-075
In Commercial Distribution

  • 00884999049598 ()
09N46-075

  • Cytomegalovirus (CMV) nucleic acid IVD, calibrator
Alinity m EBV AMP Kit
ABBOTT MOLECULAR INC.
09N43-095
In Commercial Distribution

  • 00884999049505 ()
09N43-095

  • Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Alinity m EBV CTRL Kit
ABBOTT MOLECULAR INC.
09N43-085
In Commercial Distribution

  • 00884999049499 ()
09N43-085

  • Epstein-Barr virus (EBV) nucleic acid IVD, control
Alinity m EBV CTRL Kit
ABBOTT MOLECULAR INC.
09N43-075
In Commercial Distribution

  • 00884999049482 ()
09N43-075

  • Epstein-Barr virus (EBV) nucleic acid IVD, calibrator
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 Resp-4-Plex CTRL Kit
ABBOTT MOLECULAR INC.
09N79-086
In Commercial Distribution

  • 00884999049406 ()
09N79-086

  • Multiple-genus respiratory virus nucleic acid IVD, control
Alinity m Resp-4-Plex AMP Kit
ABBOTT MOLECULAR INC.
09N79-096
In Commercial Distribution

  • 00884999049390 ()
09N79-096

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Alinity m Resp-4-Plex Application Specification File
ABBOTT MOLECULAR INC.
09N79-03A
In Commercial Distribution

  • 00884999049383 ()
09N79-03A

  • Laboratory instrument/analyser application software IVD
Alinity m Resp-4-Plex CTRL Kit
ABBOTT MOLECULAR INC.
09N79-085
In Commercial Distribution

  • 00884999049376 ()
09N79-085

  • Multiple-genus respiratory virus nucleic acid IVD, control
Alinity m Resp 4 Plex AMP Kit
ABBOTT MOLECULAR INC.
09N79-095
In Commercial Distribution

  • 00884999049369 ()
09N79-095

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Alinity m Bottle for Ethanol Use
ABBOTT MOLECULAR INC.
09N20-012
In Commercial Distribution

  • 00884999049314 ()
09N20-012

  • Assay container IVD, single-use
Alinity m SARS-CoV-2 AMP Kit
ABBOTT MOLECULAR INC.
09N78-095
In Commercial Distribution

  • 00884999049222 ()
09N78-095

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Alinity m SARS-CoV-2 CTRL Kit
ABBOTT MOLECULAR INC.
09N78-085
In Commercial Distribution

  • 00884999049208 ()
09N78-085

  • SARS-CoV-2 nucleic acid IVD, control
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
No Description
ABBOTT MOLECULAR INC.
09N19-012
In Commercial Distribution

  • 30884999050410 ()
  • 20884999050413 ()
  • 00884999048898 ()
09N19-012

  • General-purpose absorbent tip applicator/swab, single-use
  • General specimen container IVD, no additive/medium
Alinity m HR HPV Application Specification File
ABBOTT MOLECULAR INC.
09N15-03A
In Commercial Distribution

  • 00884999048676 ()
09N15-03A

  • Laboratory instrument/analyser application software IVD
Alinity m STI Application Specification File
ABBOTT MOLECULAR INC.
09N17-03A
In Commercial Distribution

  • 00884999048669 ()
09N17-03A

  • Laboratory instrument/analyser application software IVD
Alinity m HCV Application Specification File
ABBOTT MOLECULAR INC.
08N50-03A
In Commercial Distribution

  • 00884999048652 ()
08N50-03A

  • Laboratory instrument/analyser application software IVD
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