Device Description : This independent CF control is intended for in vitro diagnostic use to monitor t This independent CF control is intended for in vitro diagnostic use to monitor the entire testing process of diagnostic assays used in the detection of the CFTR gene mutations and variants.
Device Class : 2
Duns Number: 172874245
Premarket Exempt : No
Prescription Use : No
Device Description : This independent CF control is intended for in vitro diagnostic use to monitor t This independent CF control is intended for in vitro diagnostic use to monitor the entire testing process of diagnostic assays used in the detection of the CFTR gene mutations and variants.
Device Class : 2
Duns Number: 172874245
Premarket Exempt : No
Prescription Use : No
Device Description : External quality controls to monitor the performance of in vitro laboratory nucl External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray Pneumonia Panel or Pneumonia Panel plus assay on the FilmArray systems.
Device Class : 2
Duns Number: 172874245
Premarket Exempt : No
Prescription Use : No
Device Description : External quality controls to monitor the performance of in vitro laboratory nucl External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray RP2 and RP2plus assay on the FilmArray 2.0/Torch systems.
Device Class : 2
Duns Number: 172874245
Premarket Exempt : No
Prescription Use : No
Device Description : External quality controls to monitor the performance of in vitro laboratory nucl External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray RP EZ assay on the FilmArray systems.
Device Class : 2
Duns Number: 172874245
Premarket Exempt : No
Prescription Use : No
Device Description : External quality controls to monitor the performance of in vitro laboratory nucl External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray® NGDS Warrior Panel performed on FilmArray systems.
Device Class : 2
Duns Number: 172874245
Premarket Exempt : No
Prescription Use : No
Device Description : Reference material to monitor the performance of the in vitro quantitative detec Reference material to monitor the performance of the in vitro quantitative detection of BCR-ABL1 and ABL1 mRNA transcripts for Xpert BCR-ABL Ultra assay on the Cepheid GeneXpert system.
Device Class : 2
Duns Number: 172874245
Premarket Exempt : Yes
Prescription Use : No
Device Description : External quality controls to monitor the performance of in vitro laboratory nucl External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the BioFire Blood Culture Identification 2 (BCID2) Panel on the FilmArray systems.
Device Class : 2
Duns Number: 172874245
Premarket Exempt : No
Prescription Use : No
Device Description : Reference material to monitor the performance of the in vitro quantitative detec Reference material to monitor the performance of the in vitro quantitative detection of BCR-ABL1 and ABL1 mRNA transcripts for Xpert BCR-ABL Ultra assay on the Cepheid GeneXpert system.
Device Class : 2
Duns Number: 172874245
Premarket Exempt : Yes
Prescription Use : No
Device Description : External quality controls to monitor the performance of in vitro laboratory nucl External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray RP2.1/ RP2.1plus assay on the FilmArray 2.0/Torch systems.
Device Class : 2
Duns Number: 172874245
Premarket Exempt : No
Prescription Use : No