Product Name RS Description Ref. Presentation
CA LI
BR AT
O RS
BIOPHEN™ Plasma Calibrator
CE-IVD 510(K)
Normal Human Plasma for the calibration of AT, PC, PS, Free PS, FVII-X, Plasminogen, FII, FV, FVII, FVIII:C, FIX, FX, FXI, FXII, FXIII, Fibrinogen, α2-AP, vWF: Ag
222101 12 x 1 mL
BIOPHEN™ V-L Plasma Calibrator
CE-IVD 510(K)
For the calibration of FV-L assay 222401
CAL1: 3 x 0.5 mL
CAL2: 3 x 0.5 mL
CAL3: 3 x 0.5 mL BIOPHEN™ Factor VIIa Calibrator
CE-IVD For the calibration of FVIIa activity measurements
226301 6 x 2 mL
Product Name RS Description Ref. Presentation
CO N
TR O
LS
BIOPHEN™ Normal Control Plasma
CE-IVD 510(K)
Normal quality control plasma for AT, PC, PS, Free PS, FVII-X, Plasminogen, FII, FV, FVII, FVIII:C, FIX, FX, FXI, FXII, FXIII, Fibrinogen, aPCr (%FVL), lupus anticoagulant, PT/INR/%, aPTT, vWF: Ag, α2 AP and Thrombin Time
223201 12 x 1 mL
BIOPHEN™ Abnormal Control Plasma
CE-IVD 510(K)
Abnormal quality control plasma for AT, PC, PS, Free PS, FVII-X, Plasminogen, FII, FV, FVII, FVIII:C, FIX, FX, FXI, FXII, FXIII, Fibrinogen, lupus anticoagulant, PT/INR/%, aPTT, vWF: Ag and α2 AP
223301 12 x 1 mL
LA Control Plasma CE-IVD
Quality control plasmas, weak and high positive, for Lupus Anticoagulant
SC081K C1: 6 x 0.5 mL
C2: 6 x 0.5 mL
LA Control Plasma Weak CE-IVD
Quality control plasmas, weak positive, for Lupus Anticoagulant.
SC082K C1: 6 x 0.5 mL
LA Control Plasma High CE-IVD
Quality control plasmas, high positive, for Lupus Anticoagulant.
SC083K C2: 6 x 0.5 mL
BIOPHEN™ V-L Control Plasma
CE-IVD 510(K)
Quality control of FV-L 223405 12 x 0.5 mL
BIOPHEN™ FVIIa Control Set
CE-IVD Quality control of FVIIa activity measurements.
224901 on- demand
C1: 3 x 1 mL
C2: 3 x 1 mL
BIOPHEN™ FXIa Control Set
RUO Quality control of FXIa activity measurements 224801
C1: 3 x 1 mL
C2: 3 x 1 mL
BIOPHEN™ FIXa Control Set
RUO Quality control of FIXa activity measurements
224601 on- demand
C1: 6 x 1 mL
C2: 6 x 1 mL
EASYPLASMA™ Control Set CE-IVD
Routine quality control plasmasfor PT/INR/%, aPTT, Fibrinogen (Fbg) and Thrombin Time (TT) C1 Normal control plasma: Normal citrated human plasma, lyophilized. C2 Abnormal control plasma: Abnormal citrated human plasma, lyophilized
225601
C1: 6 x 1 mL
C2: 6 x 1 mL
LUPUS ANTICOAGULANT
ANTITHROMBIN FIXa FVIIa
FACTOR V LEIDEN FXIa
PROTEIN S
PROTEIN C
LUPUS ANTICOAGULANT
ANTITHROMBIN FIXa FVIIa
FACTOR V LEIDEN FXIa
PROTEIN S
PROTEIN C
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