Address:2800 Woods Hollow Road,Madison,WI,53711,US
Device Description : Abbott mSample Preparation System is a nucleic acid extraction system used for l Abbott mSample Preparation System is a nucleic acid extraction system used for laboratory isolation of RNA from biological samples.
Device Class : 1
Duns Number: 089855696
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Abbott mSample Preparation System DNA is a nucleic acid extraction system used f Abbott mSample Preparation System DNA is a nucleic acid extraction system used for laboratory isolation of DNA from biological samples.
Device Class : 1
Duns Number: 089855696
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Abbott mSample Preparation System DBS Buffer
Device Class : 1
Duns Number: 089855696
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Lysis buffer used to lyse cells for nucleic acid extraction.
Device Class : 1
Duns Number: 089855696
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Qualitative multiplex polymerase chain reaction (PCR) test intended to detect th Qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in 5 microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) using matched tumor and normal DNA obtained from formalin fixed paraffin-embedded (FFPE) colorectal tissue sections.
Device Class : 2
Duns Number: 089855696
Premarket Exempt : No
Prescription Use : Yes
Device Description : Spectral calibration standard used with the Applied Biosystems® 3500 Dx Genetic Spectral calibration standard used with the Applied Biosystems® 3500 Dx Genetic Analyzer to generate a multicomponent matrix that is applied during the subsequent analysis of amplification products from the OncoMate™ MSI Dx Analysis System.
Device Class : 2
Duns Number: 089855696
Premarket Exempt : No
Prescription Use : No
Device Description : The Maxwell® CSC Instrument is a nucleic acid extraction instrument used in comb The Maxwell® CSC Instrument is a nucleic acid extraction instrument used in combination with Maxwell® CSC reagent kits to perform automated isolation of nucleic acids from biological samples.
Device Class : 1
Duns Number: 089855696
Premarket Exempt : Yes
Prescription Use : No
Device Description : The Maxwell® CSC RNA Blood Kit is a reagent kit used in combination with Maxwell The Maxwell® CSC RNA Blood Kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of RNA from whole human blood samples.
Device Class : 1
Duns Number: 089855696
Premarket Exempt : Yes
Prescription Use : No
Device Description : The Maxwell® CSC RNA FFPE kit is a reagent kit used in combination with Maxwell® The Maxwell® CSC RNA FFPE kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of RNA from FFPE (formalin fixed, paraffin embedded) tissue samples.
Device Class : 1
Duns Number: 089855696
Premarket Exempt : Yes
Prescription Use : No
Device Description : The Maxwell® CSC DNA FFPE Kit is a reagent kit used in combination with Maxwell® The Maxwell® CSC DNA FFPE Kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of DNA from FFPE (formalin fixed, paraffin embedded) tissue samples.
Device Class : 1
Duns Number: 089855696
Premarket Exempt : Yes
Prescription Use : No