Address:11710 Peel Circle,La Vista,NE,68128,US
Device Description : A direct-draw blood collection tube for the preservation of whole blood specimen A direct-draw blood collection tube for the preservation of whole blood specimens for immunophenotyping by flow cytometry. 4 ml vials.
Device Class :
Duns Number: 072915986
Premarket Exempt : No
Prescription Use : No
Device Description : Cell-Free DNA BCT is a direct-draw venous whole blood collection device intended Cell-Free DNA BCT is a direct-draw venous whole blood collection device intended for the collection,stabilization, and transport of venous whole blood samples for use in conjunction with cell-free DNAnext- generation sequencing liquid biopsy assays that have been cleared or approved for use with samplescollected in the Cell-Free DNA BCT device.
Device Class : 2
Duns Number: 072915986
Premarket Exempt : No
Prescription Use : Yes
Device Description : A positive procedural control for monitoring immunophenotyping by flow cytometry A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials Normal level.
Device Class : 2
Duns Number: 072915986
Premarket Exempt : No
Prescription Use : No
Device Description : A positive procedural control for monitoring immunophenotyping by flow cytometry A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials of CD4L level.
Device Class : 2
Duns Number: 072915986
Premarket Exempt : No
Prescription Use : No
Device Description : A positive procedural control for monitoring immunophenotyping by flow cytometry A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials Normal level.
Device Class : 2
Duns Number: 072915986
Premarket Exempt : No
Prescription Use : No
Device Description : A positive procedural control for monitoring immunophenotyping by flow cytometry A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials of CD4L level.
Device Class : 2
Duns Number: 072915986
Premarket Exempt : No
Prescription Use : No
Device Description : Para 12® Plus is an assayed hematology control for evaluating the accuracy and p Para 12® Plus is an assayed hematology control for evaluating the accuracy and precision of hematologyinstruments that provide a white blood cell differential.
Device Class : 2
Duns Number: 072915986
Premarket Exempt : No
Prescription Use : Yes
Device Description : A hematology calibrator assayed for Beckman Coulter®, Abbott, Horiba Medical, HT A hematology calibrator assayed for Beckman Coulter®, Abbott, Horiba Medical, HTI, and Mindray instruments. Contains 3 vials.
Device Class : 2
Duns Number: 072915986
Premarket Exempt : No
Prescription Use : No
Device Description : Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC) counts, crystal identification, and white blood cell differentiation. Contains 6 vials of L1-CC.
Device Class : 2
Duns Number: 072915986
Premarket Exempt : No
Prescription Use : No
Device Description : A hematology calibrator assayed for the Abbott CELL-DYN® 3200, 3500, 3700 and Ru A hematology calibrator assayed for the Abbott CELL-DYN® 3200, 3500, 3700 and Ruby® analyzers. Contains 2 vials.
Device Class : 2
Duns Number: 072915986
Premarket Exempt : No
Prescription Use : No