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
81 80
OTHER
Product Name RS
Description Ref. Presentation Approximative Content
CA LI
BR AT
O RS
PT Calibrator Set
CE-IVD
Five certified plasmas for PT/ INR and PT% calibration and/or for verification of local ISI test system
SC084K
C1: 2 x 1 mL INR 1.00
C2: 2 x 1 mL INR 2.00
C3: 2 x 1 mL INR 3.00
C4: 2 x 1 mL INR 4.00
C5: 2 x 1 mL INR 5.00
BIOPHEN™ V-L Plasma Calibrator
CE-IVD 510(k)
For the calibration of FV-L assay 222401
C1: 3 x 0.5 mL 10 %
C2: 3 x 0.5 mL 25 %
C3: 3 x 0.5 mL 50 %
BIOPHEN™ Calibrator Factor VIIa
CE-IVD For the calibration of FVIIa activity measurements
226301 6 x 2 mL 400 mIU/mL
CO N
TR O
LS
LA Control Plasma CE-IVD
Quality control plasmas, weak and high positive, of Lupus Anticoagulant
SC081K C1: 6 x 0.5 mL Ratio 1.40
C2: 6 x 0.5 mL Ratio 2.40
LA Control Plasma Weak
CE-IVD
Quality control plasmas, weak positive, of Lupus Anticoagulant
SC082K C1: 6 x 0.5 mL Ratio 1.40
LA Control Plasma High
CE-IVD
Quality control plasmas, high positive, of Lupus Anticoagulant
SC083K C2: 6 x 0.5 mL Ratio 2.40
BIOPHEN™ V-L Control Plasma
CE-IVD 510(k)
Quality control of FV-L 223405 12 x 0.5 mL 40 %
BIOPHEN™ FVIIa Control Set
CE-IVD Quality control of FVIIa activity measurements
224901 on- demand
C1: 3 x 1 mL 75.00 mIU/mL
C2: 3 x 1 mL 250.00 mIU/mL
Product Name RS Description Ref. Presentation
Approximative Content
CO N
TR O
LS
BIOPHEN™ FXIa Control Set
RUO Quality control of FXIa activity measurements
224801 C1: 3 x 1 mL 10.00 mIU/mL
C2: 3 x 1 mL 30.00 mIU/mL
BIOPHEN™ FIXa Control Set
RUO Quality control of FIXa activity measurements
224601 C1: 6 x 1 mL 6.00 mIU/mL
C2: 6 x 1 mL 12.00 mIU/mL
High Positive DDimer Control Plasma
RUO High Positive DDimer Control Plasma
SC101K 6 x 1 mL 2.00 μg/mL
Negative DDimer Control Plasma
RUO Negative DDimer Control Plasma
SC102K 6 x 1 mL 0.50 μg/mL
DDimer Control Plasma Low
RUO DDimer Control Plasma Low SC103K 6 x 1 mL 0.80 μg/mL
SPECIFICS CALIBRATORS & CONTROLS
SPECIFICS CALIBRATORS & CONTROLS
PT aPTT
ACTIVATED PROTEIN C RESISTANCE
LUPUS ANTICOAGULANT FXIa FIXa FVIIa
THROMBOPHILIA GLOBAL &
ROUTINE TESTS
PT aPTT
ACTIVATED PROTEIN C RESISTANCE
LUPUS ANTICOAGULANT FXIa FIXa FVIIa
THROMBOPHILIA GLOBAL &
ROUTINE TESTS
