Calibrators and Controls

Multi-Calibrators and Controls

BIOPHEN™ Plasma Calibrator CE-IVD
510(k)		 Normal Human Plasma for the calibration of some coagulation factors . 222101 12x1mL
BIOPHEN™ Normal Control Plasma CE-IVD
510(k)		 Normal Control Plas ma for coagulation as say quality control. 223201 12x1mL
BIOPHEN™ Abnormal Control Plasma CE-IVD
510(k)		 Abnormal Control Plasma for coagulation as say quality control. 223301 12x1 mL
EASYPLASMA™ Calibrator CE-IVD Routine calibrator plas mas with limited numbers of parameters . 226601 6x1mL
EASYPLASMA™ Control Set CE-IVD Routine control plas mas with limited numbers of parameters 225601 C1, C2: 6x1mL each

Activated Factor Specific Calibrators and Controls

BIOPHEN™ FVIIa Calibrator CE-IVD Calibrator for Factor VIIa assays . 226301 6x2mL
BIOPHEN™ FVIIa Control Set CE-IVD Factor VIIa quality control set. 224901 C1,C2: 3x1mL each
BIOPHEN™ FIXa Control Set RUO Factor IXa quality control set. 224601 C1,C2: 6x1mL each
BIOPHEN™ FXIa Control Set RUO Factor XIa quality control set. 224801 C1,C2: 3x1mL each

Heparins and their Analogues

Low Molecular Weight Heparin (LMWH)

BIOPHEN™ Heparin Calibrator CE-IVD
510(k)		 LMWH calibrator plasma set. 222001 5 levels, 4x1mL each
BIOPHEN™ LMWH Control CE-IVD
510(k)		 LMWH quality control plasma set. 223001 C3,C4: 6x1mL each
223801 C3: 12x1mL
224201 C4: 12x1mL
BIOPHEN™ LMWH Control Low CE-IVD
510(k)		 LMWH quality control plasma set, low range. 223701 CI, CII: 6x1mL each
224301 CI: 12x1mL
224401 CII: 12x1mL

Unfractionated Heparin (UFH)

BIOPHEN™ UFH Calibrator CE-IVD
510(k)		 UFH calibrator plas ma set. 222301 5 levels, 4x1mL each
BIOPHEN™ UFH Control CE-IVD
510(k)		 LMWH quality control plasma set. 223101 C1,C2: 6x1mL each
224101 C1: 12x1mL
223901 C2: 12x1mL

Orgaran®

BIOPHEN™ Orgaran® Calibrator CE-IVD Orgaran® calibrator plas ma set. 222201 5 levels , 4 x 1 mL each
BIOPHEN™ Orgaran® Control CE-IVD
 Orgaran® quality control plasma set. 223501 2 levels , 6 x 1 mL each

Arixtra®

BIOPHEN™ Arixtra® Calibrator CE-IVD Arixtra® calibrator plas ma set. 222501 4 levels , 3 x 1 mL each
BIOPHEN™ Arixtra® Control CE-IVD
 Arixtra® quality control plasma set. 224001 2 levels , 6 x 1 mL each

Direct Anti-Xa Inhibitors

Rivaroxaban

BIOPHEN™ Rivaroxaban Calibrator Low CE-IVD Rivaroxaban calibrator plas ma set, low range. 226001 3 levels , 4 x 1 mL each
BIOPHEN™ Rivaroxaban Control Low CE-IVD Rivaroxaban quality control plas ma set, low range. 225101 2 levels , 6 x 1 mL each
BIOPHEN™ Rivaroxaban Calibrator CE-IVD Rivaroxaban calibrator plas ma set, s tandard range. 222701 3 levels , 4 x 1 mL each
BIOPHEN™ Rivaroxaban Control CE-IVD Rivaroxaban quality control plas ma set, s tandard range. 224501 2 levels , 6 x 1 mL each

Apixaban

BIOPHEN™ Apixaban Calibrator Low CE-IVD Apixaban calibrator plas ma set, low range. 226101 3 levels , 4 x 1 mL each
BIOPHEN™ Apixaban Control Low CE-IVD Apixaban quality control plas ma set, low range. 225201 2 levels , 6 x 1 mL each
BIOPHEN™ Apixaban Calibrator CE-IVD Apixaban calibrator plas ma set, s tandard range. 226201 3 levels , 4 x 1 mL each
BIOPHEN™ Apixaban Control CE-IVD Apixaban quality control plas ma set, s tandard range. 225301 2 levels , 6 x 1 mL each

Edoxaban

BIOPHEN™ Edoxaban Calibrator Low CE-IVD Edoxaban calibrator plas ma set, low range. 226401 3 levels , 4 x 1 mL each
BIOPHEN™ Edoxaban Control Low CE-IVD Edoxaban quality control plas ma set, low range. 225401 2 levels , 6 x 1 mL each
BIOPHEN™ Edoxaban Calibrator CE-IVD Edoxaban calibrator plas ma set, s tandard range. 226501 3 levels , 4 x 1 mL each
BIOPHEN™ Edoxaban Control CE-IVD Edoxaban quality control plas ma set, s tandard range. 225501 2 levels , 6 x 1 mL each

Direct Thrombin Inhibitors

Dabigatran

BIOPHEN™ Dabigatran Calibrator Low CE-IVD Dabigatran calibrator plas ma set, low range. 222901 3 levels , 4 x 1 mL each
BIOPHEN™ Dabigatran Control Low CE-IVD Dabigatran quality control plas ma set, low range. 225001 2 levels , 6 x 1 mL each
BIOPHEN™ Dabigatran Plasma
Calibrator		 CE-IVD Dabigatran calibrator plas ma set, s tandard range. 222801 3 levels , 4 x 1 mL each
BIOPHEN™ Dabigatran Control Plasma CE-IVD Dabigatran quality control plas ma set, s tandard range. 222001 2 levels , 6 x 1 mL each

Argatroban

Argatroban Plasma Calibrator CE-IVD Argatroban calibrator plasma set. SC030K 5 levels, 4x1mL each
Argatroban Control Plasma CE-IVD Argatroban quality control plasma set SC035K 2 levels, 6x1mL each

Bivalirudin

BIOPHEN™ Bivalirudin Calibrator CE-IVD Bivalirudin calibrator plasma set 226701 5 levels, 2x1 mL each
BIOPHEN™ Bivalirudin Control CE-IVD Bivalirudin quality control plas ma set. 225701 2 levels, 3x1mL each

Activated Protein C Resistance

BIOPHEN™ V-L CAL (undiluted) CE-IVD aPC resistance calibration plasma set 222401 3 levels, 3x0.5mL each
BIOPHEN™ Act. PC-r Control Plasma CE-IVD aPC abnormal quality control set. 223405 12x0.5mL

Protein S

Plasma Protein S control RUO Protein S (free and total) quality control plas ma set for ELISA method. SC050K 2 levels, 3x0.5mL each

D-Dimers

High Positive DDimer Control Plasma RUO Pathological concentration (about 2 μg/mL). SC101K 6 x 1 mL
Negative DDimer Control Plasma RUO Concentration les s than 0.40 μg/mL. SC102K 6 x 1 mL
DDimer Control Plasma Low RUO Pathological concentration (about 0.6 μg/mL). SC103K 6 x 1 mL

Lupus Anticoagulant

LA Control Plasma CE-IVD Set of lyophilized quality control plasmas , weak and high positive, for use in Lupus Anticoagulant clotting assays. SC081K C1, C2: 6 x 0.5 mL each
LA Control Plasma Weak CE-IVD Set of lyophilized quality control plasmas, weak positive, for use in Lupus Anticoagulant in vitro clotting assays. SC082K C1: 6 x 0.5 mL
LA Control Plasma High CE-IVD Set of lyophilized quality control plasmas, high positive, for use in Lupus Anticoagulant in vitro clotting assays. SC083K C2: 6 x 0.5 mL

Fibrinolysis

FPA control RUO Quality control plasma set for FPA SC015K 2 levels, 3x1mL each
Plasma PAI-1 control RUO Quality control plasma set for PAI-1 SC011K 2 levels, 3x1mL each
Plasma U.T.A. control RUO Quality control plas ma set for Annexin V, tPA and uPA SC017K 2 levels, 3x1mL each