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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 - 10758750008728

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

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

Vysis - 00884999027084

CEP 12 SpectrumOrange
ABBOTT MOLECULAR INC.
07J22-012
In Commercial Distribution

  • 00884999027084 ()
07J22-012

  • Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe

Vysis - 00884999027077

CEP 8 SpectrumOrange
ABBOTT MOLECULAR INC.
07J22-008
In Commercial Distribution

  • 00884999027077 ()
07J22-008

  • Cancer/tumour-associated aneuploidy IVD, probe

Vysis - 00884999027060

ProbeChek Low Level Male 95% XX/5% XY
ABBOTT MOLECULAR INC.
07J21-012
In Commercial Distribution

  • 00884999027060 ()
07J21-012

  • Cancer/tumour-associated aneuploidy IVD, probe

Vysis - 00884999027053

ProbeChek Low Level Female 5% XX/95% XY
ABBOTT MOLECULAR INC.
07J21-011
In Commercial Distribution

  • 00884999027053 ()
07J21-011

  • Cancer/tumour-associated aneuploidy IVD, probe

Vysis - 00884999027046

ProbeChek Positive Control 10% Trisomy 8/12
ABBOTT MOLECULAR INC.
07J21-002
In Commercial Distribution

  • 00884999027046 ()
07J21-002

  • Cancer/tumour-associated aneuploidy IVD, probe

Vysis - 00884999027039

ProbeChek Negative Control 0% Trisomy 8/12
ABBOTT MOLECULAR INC.
07J21-001
In Commercial Distribution

  • 00884999027039 ()
07J21-001

  • Cancer/tumour-associated aneuploidy IVD, probe

Vysis - 00884999027022

Vysis CEP X SpectrumOrange/ Y SpectrumGreen
ABBOTT MOLECULAR INC.
07J20-050
In Commercial Distribution

  • 00884999027022 ()
07J20-050

  • Cancer/tumour-associated aneuploidy IVD, probe

Vysis - 00884999027015

CEP 12 SpectrumOrange
ABBOTT MOLECULAR INC.
07J20-012
In Commercial Distribution

  • 00884999027015 ()
07J20-012

  • Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe

Vysis - 00884999027008

CEP 8 SpectrumOrange
ABBOTT MOLECULAR INC.
07J20-008
In Commercial Distribution

  • 00884999027008 ()
07J20-008

  • Cancer/tumour-associated aneuploidy IVD, probe

Vysis - 00884999026254

Propidium Iodide Counterstain, 2 x 500 uL (400 ng/mL)
ABBOTT MOLECULAR INC.
07J06-001
In Commercial Distribution

  • 00884999026254 ()
07J06-001

  • DAPI solution IVD

Vysis - 00884999021990

Vysis LSI/WCP Hybridization Buffer 2 x 500 uL
ABBOTT MOLECULAR INC.
06J67-011
In Commercial Distribution

  • 00884999021990 ()
06J67-011

  • Nucleic acid hybridization detection IVD, reagent

Vysis - 00884999021983

Vysis LSI/WCP Hybridization Buffer 2 x 150 uL
ABBOTT MOLECULAR INC.
06J67-001
In Commercial Distribution

  • 00884999021983 ()
06J67-001

  • Nucleic acid hybridization detection IVD, reagent

Vysis - 00884999021853

Vysis CEP 7 (D7Z1) (satellite) SpectrumAqua Probe
ABBOTT MOLECULAR INC.
06J54-027
In Commercial Distribution

  • 00884999021853 ()
06J54-027

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999021846

Vysis CEP 15 (D15Z1)(satellite III) SpectrumAqua Probe
ABBOTT MOLECULAR INC.
06J54-025
In Commercial Distribution

  • 00884999021846 ()
06J54-025

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999021839

Vysis CEP 11 (D11Z1)(satellite) SpectrumAqua Probe
ABBOTT MOLECULAR INC.
06J54-021
In Commercial Distribution

  • 00884999021839 ()
06J54-021

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999021822

Vysis CEP 10 (satellite) SpectrumAqua Probe
ABBOTT MOLECULAR INC.
06J54-020
In Commercial Distribution

  • 00884999021822 ()
06J54-020

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999021815

Vysis CEP 9 (satellite) SpectrumAqua Probe
ABBOTT MOLECULAR INC.
06J54-019
In Commercial Distribution

  • 00884999021815 ()
06J54-019

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999021808

Vysis CEP 8 (D8Z2)(satellite) SpectrumAqua Probe
ABBOTT MOLECULAR INC.
06J54-018
In Commercial Distribution

  • 00884999021808 ()
06J54-018

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999021792

Vysis CEP 6 (D6Z1) (satellite) SpectrumAqua Probe
ABBOTT MOLECULAR INC.
06J54-016
In Commercial Distribution

  • 00884999021792 ()
06J54-016

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999021778

Vysis CEP 4 (satellite) SpectrumAqua Probe
ABBOTT MOLECULAR INC.
06J54-014
In Commercial Distribution

  • 00884999021778 ()
06J54-014

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999021648

DAPI II Counterstain, 2 x 500 uL (125ng/mL)
ABBOTT MOLECULAR INC.
06J50-001
In Commercial Distribution

  • 00884999021648 ()
06J50-001

  • DAPI solution IVD

Vysis - 00884999021631

DAPI III Counterstain 2 x 500 uL (42ng/mL)
ABBOTT MOLECULAR INC.
06J49-010
In Commercial Distribution

  • 00884999021631 ()
06J49-010

  • DAPI solution IVD

Vysis - 00884999021624

DAPI I Counterstain 2 x 500 uL (1000ng/mL)
ABBOTT MOLECULAR INC.
06J49-001
In Commercial Distribution

  • 00884999021624 ()
06J49-001

  • DAPI solution IVD

Vysis - 00884999020160

Vysis CEP 1 (D1Z5) (satellite) SpectrumOrange Probe
ABBOTT MOLECULAR INC.
06J39-036
In Commercial Distribution

  • 00884999020160 ()
06J39-036

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999020146

Vysis CEP 17 (D17Z1) (satellite) SpectrumAqua Probe
ABBOTT MOLECULAR INC.
06J38-027
In Commercial Distribution

  • 00884999020146 ()
06J38-027

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999020122

Vysis CEP 7 (D7Z1) (satellite) SpectrumGreen Probe
ABBOTT MOLECULAR INC.
06J37-087
In Commercial Distribution

  • 00884999020122 ()
06J37-087

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999020115

Vysis CEP 17 (D17Z1) (satellite) SpectrumGreen Probe
ABBOTT MOLECULAR INC.
06J37-027
In Commercial Distribution

  • 00884999020115 ()
06J37-027

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999020108

Vysis CEP 15 (D15Z1) (satellite III) SpectrumGreen Probe
ABBOTT MOLECULAR INC.
06J37-025
In Commercial Distribution

  • 00884999020108 ()
06J37-025

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999020092

Vysis CEP 12 (D12Z3) (satellite) SpectrumGreen Probe
ABBOTT MOLECULAR INC.
06J37-022
In Commercial Distribution

  • 00884999020092 ()
06J37-022

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999020085

Vysis CEP 11 (D11Z1) (satellite) SpectrumGreen Probe
ABBOTT MOLECULAR INC.
06J37-021
In Commercial Distribution

  • 00884999020085 ()
06J37-021

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999020078

Vysis CEP 10 (satellite) SpectrumGreen Probe
ABBOTT MOLECULAR INC.
06J37-020
In Commercial Distribution

  • 00884999020078 ()
06J37-020

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999020061

Vysis CEP 9 (satellite) SpectrumGreen Probe
ABBOTT MOLECULAR INC.
06J37-019
In Commercial Distribution

  • 00884999020061 ()
06J37-019

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999020054

Vysis CEP 8 (D8Z2) (satellite) SpectrumGreen Probe
ABBOTT MOLECULAR INC.
06J37-018
In Commercial Distribution

  • 00884999020054 ()
06J37-018

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999020030

Vysis CEP 6 (D6Z1) (satellite) SpectrumGreen Probe
ABBOTT MOLECULAR INC.
06J37-016
In Commercial Distribution

  • 00884999020030 ()
06J37-016

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999020016

Vysis CEP 4 (D17Z1) (satellite) SpectrumGreen Probe
ABBOTT MOLECULAR INC.
06J37-014
In Commercial Distribution

  • 00884999020016 ()
06J37-014

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999019928

Vysis CEP 17 (D17Z1) (satellite) SpectrumOrange Probe
ABBOTT MOLECULAR INC.
06J36-097
In Commercial Distribution

  • 00884999019928 ()
06J36-097

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999019911

Vysis CEP 1 (satellite III) SpectrumOrange Probe
ABBOTT MOLECULAR INC.
06J36-091
In Commercial Distribution

  • 00884999019911 ()
06J36-091

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999019904

Vysis CEP 10 (satellite) SpectrumOrange Probe
ABBOTT MOLECULAR INC.
06J36-090
In Commercial Distribution

  • 00884999019904 ()
06J36-090

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999019898

Vysis CEP 7 (satellite) (D7Z1) SpectrumOrange Probe
ABBOTT MOLECULAR INC.
06J36-077
In Commercial Distribution

  • 00884999019898 ()
06J36-077

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999019881

Vysis CEP 2 (satellite) (D2Z1) SpectrumOrange Probe
ABBOTT MOLECULAR INC.
06J36-037
In Commercial Distribution

  • 00884999019881 ()
06J36-037

  • Nucleic acid hybridization detection IVD, probe
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