Calibrators and Controls
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EASYPLASMA™ CalibratorCalibrator
Routine calibrator plasmas for PT/INR/%, aPTT, Fibrinogen (Fbg) and Thrombin Time (TT).
Reference Registration Presentation 226601 CE-IVD 6 x 1 mL -
BIOPHEN™ Plasma CalibratorCalibrator
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.
Reference Registration Presentation 222101 CE-IVD
510(k)12 x 1 mL -
EASYPLASMA™ Control SetControl
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.Reference Registration Presentation 225601 CE-IVD C1: 6 x 1 mL
C2: 6 x 1 mL -
BIOPHEN™ Normal Control PlasmaControl
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.
Reference Registration Presentation 223201 CE-IVD
510(k)12 x 1 mL -
BIOPHEN™ Abnormal Control PlasmaControl
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.
Reference Registration Presentation 223301 CE-IVD
510(k)12 x 1 mL
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PT Calibrator SetCalibrator
Five certified plasmas for PT/INR and PT% calibration and/or for verification of local ISI test system.
Reference Registration Presentation SC084K CE-IVD CAL1: 2 x 1 mL
CAL2: 2 x 1 mL
CAL3: 2 x 1 mL
CAL4: 2 x 1 mL
CAL5: 2 x 1 mL -
BIOPHEN™ V-L Plasma CalibratorCalibrator
For the calibration of FV-L assay.
Reference Registration Presentation 222401 CE-IVD
510(k)C1: 3 x 0.5 mL
C2: 3 x 0.5 mL
C3: 3 x 0.5 mL -
BIOPHEN™ FVIIa CalibratorCalibrator
For the calibration of FVIIa activity measurements.
Reference Registration Presentation 226301 CE-IVD 6 x 2 mL -
LA Control PlasmaControl
Quality control plasmas, weak and high positive, of Lupus Anticoagulant.
Reference Registration Presentation SC081K CE-IVD C1: 6 x 0.5 mL
C2: 6 x 0.5 mL -
LA Control Plasma WeakControl
Quality control plasmas, weak positive, of Lupus Anticoagulant.
Reference Registration Presentation SC082K CE-IVD C1: 6 x 0.5 mL -
LA Control Plasma HighControl
Quality control plasmas, high positive, of Lupus Anticoagulant.
Reference Registration Presentation SC083K CE-IVD C2: 6 x 0.5 mL -
BIOPHEN™ V-L Control PlasmaControl
Quality control of FV-L.
Reference Registration Presentation 223405 CE-IVD
510(k)12 x 0.5 mL -
BIOPHEN™ FVIIa Control SetControl
Quality control of FVIIa activity measurements.
Reference Registration Presentation 224901
on-demandCE-IVD C1: 3 x 1 mL
C2: 3 x 1 mL -
BIOPHEN™ FXIa Control SetControl
Quality control of FXIa activity measurements.
Reference Registration Presentation 224801 RUO C1: 3 x 1 mL
C2: 3 x 1 mL -
BIOPHEN™ FIXa Control SetControl
Quality control of FIXa activity measurements.
Reference Registration Presentation 224601 on-demand RUO C1: 6 x 1 mL
C2: 6 x 1 mL -
High Positive DDimer Control PlasmaControl
High Positive DDimer Control Plasma
Reference Registration Presentation SC101K RUO 6 x 1 mL -
Negative DDimer Control PlasmaControl
Negative DDimer Control Plasma
Reference Registration Presentation SC102K RUO 6 x 1 mL -
DDimer Control Plasma LowControl
DDimer Control Plasma Low
Reference Registration Presentation SC103K RUO 6 x 1 mL
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BIOPHEN™ UFH CalibratorCalibrator
UFH calibrator plasma set.
Reference Registration Presentation 222301 CE-IVD
510(k)C1: 4 x 1 mL
C2: 4 x 1 mL
C3: 4 x 1 mL
C4: 4 x 1 mL
C5: 4 x 1 mL -
BIOPHEN™ Heparin CalibratorCalibrator
LMWH calibrator plasma set.
Reference Registration Presentation 222001 CE-IVD
510(k)C1: 4 x 1 mL
C2: 4 x 1 mL
C3: 4 x 1 mL
C4: 4 x 1 mL
C5: 4 x 1 mL -
BIOPHEN™ Arixtra® CalibratorCalibrator
Arixtra® calibrator plasma set.
Reference Registration Presentation 222501 CE-IVD C1: 3 x 1 mL
C2: 3 x 1 mL
C3: 3 x 1 mL
C4: 3 x 1 mL -
BIOPHEN™ Rivaroxaban Plasma CalibratorCalibrator
Rivaroxaban calibrator plasma set, standard range.
Reference Registration Presentation 222701 CE-IVD C1: 4 x 1 mL
C2: 4 x 1 mL
C3: 4 x 1 mL -
BIOPHEN™ Rivaroxaban Calibrator LowCalibrator
Rivaroxaban calibrator plasma set, low range.
Reference Registration Presentation 226001 CE-IVD CI: 4 x 1 mL
CII: 4 x 1 mL
CIII: 4 x 1 mL -
BIOPHEN™ Apixaban CalibratorCalibrator
Apixaban calibrator plasma set, standard range.
Reference Registration Presentation 226201 CE-IVD C1: 4 x 1 mL
C2: 4 x 1 mL
C3: 4 x 1 mL -
BIOPHEN™ Apixaban Calibrator LowCalibrator
Apixaban calibrator plasma set, low range.
Reference Registration Presentation 226101 CE-IVD CI: 4 x 1 mL
CII: 4 x 1 mL
CIII: 4 x 1 mL -
BIOPHEN™ Edoxaban CalibratorCalibrator
Edoxaban calibrator plasma set, standard range.
Reference Registration Presentation 226501 CE-IVD C1: 4 x 1 mL
C2: 4 x 1 mL
C3: 4 x 1 mL -
BIOPHEN™ Edoxaban Calibrator LowCalibrator
Edoxaban calibrator plasma set, low range.
Reference Registration Presentation 226401 CE-IVD CI: 4 x 1 mL
CII: 4 x 1 mL
CIII: 4 x 1 mL -
BIOPHEN™ Orgaran® CalibratorCalibrator
Orgaran® calibrator plasma set.
Reference Registration Presentation 222201 CE-IVD C1: 4 x 1 mL
C2: 4 x 1 mL
C3: 4 x 1 mL
C4: 4 x 1 mL
C5: 4 x 1 mL -
Argatroban Plasma CalibratorCalibrator
Argatroban calibrator plasma set.
Reference Registration Presentation SC030K CE-IVD C1: 4 x 1 mL
C2: 4 x 1 mL
C3: 4 x 1 mL
C4: 4 x 1 mL
C5: 4 x 1 mL -
BIOPHEN™ Bivalirudin CalibratorCalibrator
Bivalirudin calibrator plasma set.
Reference Registration Presentation 226701 CE-IVD C1: 2 x 1 mL
C2: 2 x 1 mL
C3: 2 x 1 mL
C4: 2 x 1 mL
C5: 2 x 1 mL -
BIOPHEN™ Dabigatran Plasma CalibratorCalibrator
Dabigatran calibrator plasma set, standard range.
Reference Registration Presentation 222801 CE-IVD C1: 4 x 1 mL
C2: 4 x 1 mL
C3: 4 x 1 mL -
BIOPHEN™ Dabigatran Calibrator LowCalibrator
Dabigatran calibrator plasma set, low range.
Reference Registration Presentation 222901 CE-IVD CI: 4 x 1 mL
CII: 4 x 1 mL
CIII: 4 x 1 mL -
BIOPHEN™ UFH ControlControl
UFH quality control plasma set.
Reference Registration Presentation 223101 CE-IVD
510(k)C1: 6 x 1 mL
C2: 6 x 1 mL224101 CE-IVD
510(k)C1: 12 x 1 mL 223901 CE-IVD
510(k)C2: 12 x 1 mL -
BIOPHEN™ LMWH Control PlasmaControl
LMWH quality control plasma set.
Reference Registration Presentation 223001 CE-IVD
510(k)C3: 6 x 1 mL
C4: 6 x 1 mL223801 CE-IVD
510(k)C3: 12 x 1 mL 224201 CE-IVD
510(k)C4: 12 x 1 mL -
BIOPHEN™ LMWH Control LowControl
LMWH quality control plasma set, low range.
Reference Registration Presentation 223701 CE-IVD
510(k)CI: 6 x 1 mL
CII: 6 x 1 mL224301 CE-IVD
510(k)CI: 12 x 1 mL 224401 CE-IVD
510(k)CII: 12 x 1 mL -
BIOPHEN™ Arixtra® Control PlasmaControl
Arixtra® quality control plasma set.
Reference Registration Presentation 224001 CE-IVD C1: 6 x 1 mL
C2: 6 x 1 mL -
BIOPHEN™ Rivaroxaban Control PlasmaControl
Rivaroxaban quality control plasma set, standard range.
Reference Registration Presentation 224501 CE-IVD C1: 6 x 1 mL
C2: 6 x 1 mL -
BIOPHEN™ Rivaroxaban Control LowControl
Rivaroxaban quality control plasma set, low range.
Reference Registration Presentation 225101 CE-IVD CI: 6 x 1 mL
CII: 6 x 1 mL -
BIOPHEN™ Apixaban ControlControl
Apixaban quality control plasma set, standard range.
Reference Registration Presentation 225301 CE-IVD C1: 6 x 1 mL
C2: 6 x 1 mL -
BIOPHEN™ Apixaban Control LowControl
Apixaban quality control plasma set, low range.
Reference Registration Presentation 225201 CE-IVD CI: 6 x 1 mL
CII: 6 x 1 mL -
BIOPHEN™ Edoxaban ControlControl
Edoxaban quality control plasma set, standard range.
Reference Registration Presentation 225501 CE-IVD C1: 6 x 1 mL
C2: 6 x 1 mL -
BIOPHEN™ Edoxaban Control LowControl
Edoxaban quality control plasma set, low range.
Reference Registration Presentation 225401 CE-IVD CI: 6 x 1 mL
CII: 6 x 1 mL -
BIOPHEN™ Orgaran® ControlControl
Orgaran® quality control plasma set.
Reference Registration Presentation 223501 CE-IVD C1: 6 x 1 mL
C2: 6 x 1 mL -
Argatroban Control PlasmaControl
Argatroban quality control plasma set.
Reference Registration Presentation SC035K CE-IVD C1: 6 x 1 mL
C2: 6 x 1 mL -
BIOPHEN™ Bivalirudin ControlControl
Bivalirudin quality control plasma set.
Reference Registration Presentation 225701 CE-IVD C1: 3 x 1 mL
C2: 3 x 1 mL -
BIOPHEN™ Dabigatran Control PlasmaControl
Dabigatran quality control plasma set, standard range.
Reference Registration Presentation 224701 CE-IVD C1: 6 x 1 mL
C2: 6 x 1 mL -
BIOPHEN™ Dabigatran Control LowControl
Dabigatran quality control plasma set, low range.
Reference Registration Presentation 225001 CE-IVD CI: 6 x 1 mL
CII: 6 x 1 mL