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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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ViroSeq - 00884999007475

ViroSeq HIV-1 Genotyping System v2.0
ABBOTT MOLECULAR INC.
4J94-93
In Commercial Distribution

  • 00884999007475 ()
4J94-93

  • HIV1 genotyping IVD, kit, nucleic acid technique (NAT)

ViroSeq - 00884999007420

PCR Cleanup Kit
ABBOTT MOLECULAR INC.
4J94-73
In Commercial Distribution

  • 00884999007420 ()
4J94-73

  • Post-PCR cleanup kit IVD

Vysis - 00884999001039

Vysis LSI 4q12 Tricolor Rearrangement Probe
ABBOTT MOLECULAR INC.
01N79-020
In Commercial Distribution

  • 00884999001039 ()
01N79-020

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999001015

Vysis LSI TRA/D Dual Color Break Apart Rearrangement Probes
ABBOTT MOLECULAR INC.
01N78-020
In Commercial Distribution

  • 00884999001015 ()
01N78-020

  • Nucleic acid hybridization detection IVD, probe

RealTime - 00884999000698

Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HCV (List Number 1N30-90)
ABBOTT MOLECULAR INC.
1N30-66
In Commercial Distribution

  • 00884999000698 ()
1N30-66

  • DNA anti-contamination enzyme reagent IVD

Vysis - 00884999000544

Vysis LSI D13S319 SpectrumOrange/LSI 13q34 SpectrumGreen Probes
ABBOTT MOLECULAR INC.
01N20-020
In Commercial Distribution

  • 00884999000544 ()
01N20-020

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999000537

Vysis LSI ATM SpectrumOrange/CEP 11 SpectrumGreen Probes
ABBOTT MOLECULAR INC.
01N18-020
In Commercial Distribution

  • 00884999000537 ()
01N18-020

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999000520

Vysis LSI TP53 SpectrumOrange/CEP 17 SpectrumGreen Probes
ABBOTT MOLECULAR INC.
01N17-020
In Commercial Distribution

  • 00884999000520 ()
01N17-020

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999000490

Vysis LSI TUPLE1 SpectrumOrange/TelVysion 22q SpectrumGreen
ABBOTT MOLECULAR INC.
01N14-010
In Commercial Distribution

  • 00884999000490 ()
01N14-010

  • Nucleic acid hybridization detection IVD, probe

CytoCell myProbes - 05055844934726

MPH56962 CKS1B in FITC Spectrum v2 (ASR)
CYTOCELL LIMITED
MPH56962
In Commercial Distribution

  • 05055844934726 ()


  • Assay development analyte-specific reagent IVD
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