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Device Description : The CMV Brite™ Turbo Kit is intended for the qualitative detection of Cytomegalo The CMV Brite™ Turbo Kit is intended for the qualitative detection of Cytomegalovirus (CMV) lower matrix protein pp65 by indirect immunofluorescence in isolated peripheral blood leukocytes obtained from EDTA and heparin anticoagulated human peripheral blood. The detection of CMV pp65 in human leukocytes aids in the diagnosis of acute or reactivated CMV infection.
Device Class : 2
Duns Number: 490578678
Premarket Exempt : No
Prescription Use : No
Device Description : CMV Brite™ Turbo Control Slides are a component of the CMV Brite™ Turbo kit whic CMV Brite™ Turbo Control Slides are a component of the CMV Brite™ Turbo kit which can be used as a control in the fluorescence staining of this kit. Slides with a positive and negative side are provided in a sealed pouch with desiccant and are ready to use. Positive side contains pp65 positive sf9 cells. Cells are fixated. This product is registered as “in-vitro diagnostic use only” as a component of the CMV Brite™ Turbo kit with the FDA.
Device Class : 2
Duns Number: 490578678
Premarket Exempt : No
Prescription Use : No
Device Description : The CMV Brite™ Kit is intended for the qualitative detection of Cytomegalovirus The CMV Brite™ Kit is intended for the qualitative detection of Cytomegalovirus (CMV) lower matrix protein pp65 by indirect immunofluorescence in isolated peripheral blood leukocytes obtained from EDTA and heparin anticoagulated human peripheral blood. The detection of CMV pp65 in human leukocytes aids in the diagnosis of acute or reactivated CMV infection.
Device Class : 2
Duns Number: 490578678
Premarket Exempt : No
Prescription Use : No
Device Description : The CMV Brite™ Kit is intended for the qualitative detection of Cytomegalovirus The CMV Brite™ Kit is intended for the qualitative detection of Cytomegalovirus (CMV) lower matrix protein pp65 by indirect immunofluorescence in isolated peripheral blood leukocytes obtained from EDTA and heparin anticoagulated human peripheral blood. The detection of CMV pp65 in human leukocytes aids in the diagnosis of acute or reactivated CMV infection.
Device Class : 2
Duns Number: 490578678
Premarket Exempt : No
Prescription Use : No
Device Description : Reagent A is a component of the CMV Brite™ Turbo kit which can be used in direct Reagent A is a component of the CMV Brite™ Turbo kit which can be used in direct lysis of peripheral blood erythrocytes. This product is registered as “in-vitro diagnostic use only” as a component of the CMV Brite™ Turbo kit with the FDA.
Device Class : 2
Duns Number: 490578678
Premarket Exempt : No
Prescription Use : No
Device Description : Reagent B is a component of the CMV Brite™ Turbo kit which can be used as a fixa Reagent B is a component of the CMV Brite™ Turbo kit which can be used as a fixative peripheral blood leukocytes on slides. This product is registered as “in-vitro diagnostic use only” as a component of the CMV Brite™ Turbo kit with the FDA.
Device Class : 2
Duns Number: 490578678
Premarket Exempt : No
Prescription Use : No
Device Description : Reagent C is a component of the CMV Brite™ Turbo kit which can be used as a perm Reagent C is a component of the CMV Brite™ Turbo kit which can be used as a permeabilization solution for peripheral blood leukocytes on slides. This product is registered as “in-vitro diagnostic use only” as a component of the CMV Brite™ Turbo kit with the FDA.
Device Class : 2
Duns Number: 490578678
Premarket Exempt : No
Prescription Use : No
Device Description : Reagent D is a component of the CMV Brite™ Turbo kit which can be used in immuno Reagent D is a component of the CMV Brite™ Turbo kit which can be used in immunofluorescence staining. This product is registered as “in-vitro diagnostic use only” as a component of the CMV Brite™ Turbo kit with the FDA.
Device Class : 2
Duns Number: 490578678
Premarket Exempt : No
Prescription Use : No
Device Description : Reagent E is a component of the CMV Brite™ Turbo kit which can be used in immuno Reagent E is a component of the CMV Brite™ Turbo kit which can be used in immunofluorescence staining. This product is registered as “in-vitro diagnostic use only” as a component of the CMV Brite™ Turbo kit with the FDA.
Device Class : 2
Duns Number: 490578678
Premarket Exempt : No
Prescription Use : No