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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 Type Device Class Implantable

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Alinity m - 00884999049383

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 - 00884999049185

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

RealTime - 00884999049055

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

Alinity m - 00884999048676

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 - 00884999048669

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 - 00884999048652

Alinity m HCV Application Specification File
ABBOTT MOLECULAR INC.
08N50-03A
In Commercial Distribution

  • 00884999048652 ()
08N50-03A

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999048645

Alinity m HBV Application Specification File
ABBOTT MOLECULAR INC.
08N47-03A
In Commercial Distribution

  • 00884999048645 ()
08N47-03A

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999048638

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

  • 00884999048638 ()
08N45-03A

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999048065

Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM
ABBOTT MOLECULAR INC.
06L83-008
In Commercial Distribution

  • 00884999048065 ()
06L83-008

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999047792

Abbott RealTime IDH1m2000rt Application CD-ROM
ABBOTT MOLECULAR INC.
08N90-006
In Commercial Distribution

  • 00884999047792 ()
08N90-006

  • Laboratory instrument/analyser application software IVD
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