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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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ARROW - 00801902098962

Arrow(R) PICC Kit featuring Chlorag+ard(R) Technology with Pressure Injectable, Blue Flex Tip (R) Catheter
TELEFLEX INCORPORATED
IPN032858
In Commercial Distribution

  • 30801902098963 ()
  • 00801902098962 ()
ASK-45552-RWJ3

  • Centrally-inserted central venous catheter

Hologic - 15420045506633

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

Hologic - 15420045506619

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

Hologic - 15420045506602

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

Hologic - 15420045506596

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

Hologic - 15420045506572

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 - 00884999031647

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 - 00884999029392

Vysis LSI MYB (6q23) SpectrumOrange Probe
ABBOTT MOLECULAR INC.
07J86-011
In Commercial Distribution

  • 00884999029392 ()
07J86-011

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999029156

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

Vysis - 00884999027091

Vysis CEP X SpectrumOrange/ Y SpectrumGreen
ABBOTT MOLECULAR INC.
07J22-050
In Commercial Distribution

  • 00884999027091 ()
07J22-050

  • Cancer/tumour-associated aneuploidy IVD, probe
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