Calibrators and Controls

Routine calibrator plasmas for PT/INR/%, aPTT, Fibrinogen (Fbg) and Thrombin Time (TT).

Reference	Registration	Presentation
226601	CE-IVD	6 x 1 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Plasma Calibrator

Calibrator

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

EASYPLASMA™ Control Set

Control

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Normal Control Plasma

Control

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Abnormal Control Plasma

Control

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

PT Calibrator Set

Calibrator

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ V-L Plasma Calibrator

Calibrator

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ FVIIa Calibrator

Calibrator

For the calibration of FVIIa activity measurements.

Reference	Registration	Presentation
226301	CE-IVD	6 x 2 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

LA Control Plasma

Control

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

LA Control Plasma Weak

Control

Quality control plasmas, weak positive, of Lupus Anticoagulant.

Reference	Registration	Presentation
SC082K	CE-IVD	C1: 6 x 0.5 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

LA Control Plasma High

Control

Quality control plasmas, high positive, of Lupus Anticoagulant.

Reference	Registration	Presentation
SC083K	CE-IVD	C2: 6 x 0.5 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ V-L Control Plasma

Control

Quality control of FV-L.

Reference	Registration	Presentation
223405	CE-IVD 510(k)	12 x 0.5 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ FVIIa Control Set

Control

Quality control of FVIIa activity measurements.

Reference	Registration	Presentation
224901 on-demand	CE-IVD	C1: 3 x 1 mL C2: 3 x 1 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ FXIa Control Set

Control

Quality control of FXIa activity measurements.

Reference	Registration	Presentation
224801	RUO	C1: 3 x 1 mL C2: 3 x 1 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ FIXa Control Set

Control

Quality control of FIXa activity measurements.

Reference	Registration	Presentation
224601 on-demand	RUO	C1: 6 x 1 mL C2: 6 x 1 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

High Positive DDimer Control Plasma

Control

High Positive DDimer Control Plasma

Reference	Registration	Presentation
SC101K	RUO	6 x 1 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

Negative DDimer Control Plasma

Control

Negative DDimer Control Plasma

Reference	Registration	Presentation
SC102K	RUO	6 x 1 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

DDimer Control Plasma Low

Control

DDimer Control Plasma Low

Reference	Registration	Presentation
SC103K	RUO	6 x 1 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ UFH Calibrator

Calibrator

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Heparin Calibrator

Calibrator

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Arixtra® Calibrator

Calibrator

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Rivaroxaban Plasma Calibrator

Calibrator

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Rivaroxaban Calibrator Low

Calibrator

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Apixaban Calibrator

Calibrator

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Apixaban Calibrator Low

Calibrator

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Edoxaban Calibrator

Calibrator

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Edoxaban Calibrator Low

Calibrator

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Orgaran® Calibrator

Calibrator

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

Argatroban Plasma Calibrator

Calibrator

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Bivalirudin Calibrator

Calibrator

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Dabigatran Plasma Calibrator

Calibrator

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Dabigatran Calibrator Low

Calibrator

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ UFH Control

Control

UFH quality control plasma set.

Reference	Registration	Presentation
223101	CE-IVD 510(k)	C1: 6 x 1 mL C2: 6 x 1 mL
224101	CE-IVD 510(k)	C1: 12 x 1 mL
223901	CE-IVD 510(k)	C2: 12 x 1 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ LMWH Control Plasma

Control

LMWH quality control plasma set.

Reference	Registration	Presentation
223001	CE-IVD 510(k)	C3: 6 x 1 mL C4: 6 x 1 mL
223801	CE-IVD 510(k)	C3: 12 x 1 mL
224201	CE-IVD 510(k)	C4: 12 x 1 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ LMWH Control Low

Control

LMWH quality control plasma set, low range.

Reference	Registration	Presentation
223701	CE-IVD 510(k)	CI: 6 x 1 mL CII: 6 x 1 mL
224301	CE-IVD 510(k)	CI: 12 x 1 mL
224401	CE-IVD 510(k)	CII: 12 x 1 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Arixtra® Control Plasma

Control

Arixtra^® quality control plasma set.

Reference	Registration	Presentation
224001	CE-IVD	C1: 6 x 1 mL C2: 6 x 1 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Rivaroxaban Control Plasma

Control

Rivaroxaban quality control plasma set, standard range.

Reference	Registration	Presentation
224501	CE-IVD	C1: 6 x 1 mL C2: 6 x 1 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Rivaroxaban Control Low

Control

Rivaroxaban quality control plasma set, low range.

Reference	Registration	Presentation
225101	CE-IVD	CI: 6 x 1 mL CII: 6 x 1 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Apixaban Control

Control

Apixaban quality control plasma set, standard range.

Reference	Registration	Presentation
225301	CE-IVD	C1: 6 x 1 mL C2: 6 x 1 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Apixaban Control Low

Control

Apixaban quality control plasma set, low range.

Reference	Registration	Presentation
225201	CE-IVD	CI: 6 x 1 mL CII: 6 x 1 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Edoxaban Control

Control

Edoxaban quality control plasma set, standard range.

Reference	Registration	Presentation
225501	CE-IVD	C1: 6 x 1 mL C2: 6 x 1 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Edoxaban Control Low

Control

Edoxaban quality control plasma set, low range.

Reference	Registration	Presentation
225401	CE-IVD	CI: 6 x 1 mL CII: 6 x 1 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Orgaran® Control

Control

Orgaran^® quality control plasma set.

Reference	Registration	Presentation
223501	CE-IVD	C1: 6 x 1 mL C2: 6 x 1 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

Argatroban Control Plasma

Control

Argatroban quality control plasma set.

Reference	Registration	Presentation
SC035K	CE-IVD	C1: 6 x 1 mL C2: 6 x 1 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Bivalirudin Control

Control

Bivalirudin quality control plasma set.

Reference	Registration	Presentation
225701	CE-IVD	C1: 3 x 1 mL C2: 3 x 1 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Dabigatran Control Plasma

Control

Dabigatran quality control plasma set, standard range.

Reference	Registration	Presentation
224701	CE-IVD	C1: 6 x 1 mL C2: 6 x 1 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

BIOPHEN™ Dabigatran Control Low

Control

Dabigatran quality control plasma set, low range.

Reference	Registration	Presentation
225001	CE-IVD	CI: 6 x 1 mL CII: 6 x 1 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

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Calibrators and Controls