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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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VITROS Immunodiagnostic Products NT-proBNP II Controls
ORTHO CLINICAL DIAGNOSTICS
6844507
In Commercial Distribution

  • 10758750032099 ()
  • 20758750032096 ()
6844507

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products CK-MB Calibrators
ORTHO CLINICAL DIAGNOSTICS
1286293
In Commercial Distribution

  • 10758750008728 ()
  • 20758750008725 ()
1286293

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay
Universal General Purpose Reagent - Universal Arm6/Red FRET.
Hologic, Inc.
UNIVERSAL ARM6/RED FRET
Not in Commercial Distribution

  • 15420045506633 ()
96-016

  • Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD
Universal General Purpose Reagent - Universal Arm4/Red FRET.
Hologic, Inc.
UNIVERSAL ARM4/RED FRET
Not in Commercial Distribution

  • 15420045506619 ()
96-014

  • Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD
Universal General Purpose Reagent - Universal Arm4/FAM FRET.
Hologic, Inc.
UNIVERSAL ARM4/FAM FRET
Not in Commercial Distribution

  • 15420045506602 ()
96-013

  • Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD
Universal General Purpose Reagent - Universal Arm3/Red FRET.
Hologic, Inc.
UNIVERSAL ARM3/RED FRET
In Commercial Distribution

  • 15420045506596 ()
96-011

  • Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD
Universal General Purpose Reagent - Universal Arm1/Red FRET.
Hologic, Inc.
UNIVERSAL ARM1/RED FRET
In Commercial Distribution

  • 15420045506572 ()
96-008

  • Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD
Vysis LSI BCR/ABL1/ASS1 Tri-Color Dual Fusion Probe (20 uL)
ABBOTT MOLECULAR INC.
08L79-020
In Commercial Distribution

  • 00884999031647 ()
08L79-020

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI MYB (6q23) SpectrumOrange Probe
ABBOTT MOLECULAR INC.
07J86-011
In Commercial Distribution

  • 00884999029392 ()
07J86-011

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI N-MYC SpectrumGreen/CEP 2 SpectrumOrange Probe
ABBOTT MOLECULAR INC.
07J72-001
In Commercial Distribution

  • 00884999029156 ()
07J72-001

  • Nucleic acid hybridization detection IVD, probe
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