GL OB
AL &
RO UT
IN E
TE ST
S FI
BR IN
OL YS
IS TH
RO M
BO PH
IL IA
RE SE
AR CH
PR IM
AR Y
HE M
OS TA
SI S
CA LI
BR AT
OR S
& CO
NT RO
LS IN
DE X
M ON
IT OR
IN G
AN TI
CO AG
UL AN
T AU
XI LI
AR Y
RE AG
EN TS
BL EE
DI NG
DI
SO RD
ER S
51 50
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 and LA
222101 12 x 1 mL
BIOPHEN™ V-L Plasma Calibrator
CE-IVD 510(K)
For the calibration of FV-L assay 222401
C1: 3 x 0,5 mL
C2: 3 x 0,5 mL
C3: 3 x 0,5 mL
BIOPHEN™ FVIIa Calibrator
CE-IVD For the calibration of FVIIa activity measurements 226301 6 x 2 mL
EASYPLASMA™ Calibrator CE-IVD
Routine calibrator plasmas for PT/INR/%, aPTT, Fibrinogen (Fbg) and Thrombin Time (TT)
226601 6 x 1 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, of 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, of Lupus Anticoagulant.
SC082K C1: 6 x 0.5 mL
LA Control Plasma High CE-IVD
Quality control plasmas, high positive, of 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
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