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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

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