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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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10 Panel Dip Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-MTD-OPI300-THC
EXPRESS DIAGNOSTICS INT'L, INC.
31060
Not in Commercial Distribution

  • B298310600 ()
31060

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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
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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