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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 - 00884999049604

Alinity m CMV CTRL Kit
ABBOTT MOLECULAR INC.
09N46-085
In Commercial Distribution

  • 00884999049604 ()
09N46-085

  • Cytomegalovirus (CMV) nucleic acid IVD, control

Alinity m - 00884999049598

Alinity m CMV CAL Kit
ABBOTT MOLECULAR INC.
09N46-075
In Commercial Distribution

  • 00884999049598 ()
09N46-075

  • Cytomegalovirus (CMV) nucleic acid IVD, calibrator

Alinity m - 00884999049499

Alinity m EBV CTRL Kit
ABBOTT MOLECULAR INC.
09N43-085
In Commercial Distribution

  • 00884999049499 ()
09N43-085

  • Epstein-Barr virus (EBV) nucleic acid IVD, control

RealTime - 00884999049109

Abbott RealTime SARS-CoV-2 Amplification Reagent Kit
ABBOTT MOLECULAR INC.
09N77-095
In Commercial Distribution

  • 00884999049109 ()
09N77-095

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

RealTime - 00884999049086

Abbott RealTime SARS-CoV-2 Control Kit
ABBOTT MOLECULAR INC.
09N77-085
In Commercial Distribution

  • 00884999049086 ()
09N77-085

  • SARS-CoV-2 nucleic acid IVD, control

Alinity m - 00884999047822

Alinity m HCV CAL Kit
ABBOTT MOLECULAR INC.
08N50-075
In Commercial Distribution

  • 00884999047822 ()
08N50-075

  • Hepatitis C virus nucleic acid IVD, calibrator

Alinity m - 00884999047808

Alinity m HBV CAL Kit
ABBOTT MOLECULAR INC.
08N47-075
In Commercial Distribution

  • 00884999047808 ()
08N47-075

  • Hepatitis B virus nucleic acid IVD, calibrator

RealTime - 00884999047358

Abbott RealTime IDH1 Amplification Reagent Kit
ABBOTT MOLECULAR INC.
08N90-090
In Commercial Distribution

  • 00884999047358 ()
08N90-090

  • Isocitrate dehydrogenase 1 (IDH1) gene mutation IVD, kit, nucleic acid technique (NAT)

RealTime - 00884999047341

Abbott RealTime IDH1 Control Kit
ABBOTT MOLECULAR INC.
08N90-080
In Commercial Distribution

  • 00884999047341 ()
08N90-080

  • Isocitrate dehydrogenase 1 (IDH1) gene mutation IVD, control

RealTime - 00884999047051

Abbott RealTime IDH2 Control Kit
ABBOTT MOLECULAR INC.
08N82-080
In Commercial Distribution

  • 00884999047051 ()


  • Isocitrate dehydrogenase 2 (IDH2) gene mutation IVD, control
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