Device Description : The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intend The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and evaluate precision and accuracy of the (qualitative) PIFA® Heparin/PF4 Rapid Assay. Included are both confirmed positive and negative control panel members.
Device Class :
Duns Number: 611245549
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intend The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and evaluate precision and accuracy of the (qualitative) PIFA® Heparin/PF4 Rapid Assay. Included are both confirmed positive and negative control panel members.
Device Class :
Duns Number: 611245549
Premarket Exempt : No
Prescription Use : No
Device Description : A collection of reagents and other associated materials intended to be used for A collection of reagents and other associated materials intended to be used for the qualitative detection of total antibodies to platelet factor 4-heparin complex in a clinical specimen within a short period, relative to standard laboratory testing procedures, using PIFA PLUSS® PF4 Rapid Assay.
Device Class :
Duns Number: 611245549
Premarket Exempt : No
Prescription Use : Yes
Device Description : A collection of reagents and other associated materials intended to be used for A collection of reagents and other associated materials intended to be used for the qualitative detection of total antibodies to platelet factor 4-heparin complex in a clinical specimen within a short period, relative to standard laboratory testing procedures, using PIFA® Heparin/PF4 Rapid Assay.
Device Class :
Duns Number: 611245549
Premarket Exempt : No
Prescription Use : Yes