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
83 82
ANTICOAGULANTS CALIBRATORS
ANTICOAGULANTS CALIBRATORS
Product Name RS
Descrip- tion Ref.
Presenta- tion
Approxi- mative Content
CA LI
BR AT
O RS
BIOPHEN™ UFH Calibrator
CE-IVD 510(K)
UFH calibrator plasma set
222301
C1: 4 x 1 mL 0.00 IU/mL
C2: 4 x 1 mL 0.35 IU/mL
C3: 4 x 1 mL 0.70 IU/mL
C4: 4 x 1 mL 1.05 IU/mL
C5: 4 x 1 mL 1.40 IU/mL
BIOPHEN™ Heparin Calibrator
CE-IVD 510(K)
LMWH calibrator plasma set
222001
C1: 4 x 1 mL 0.00 IU/mL
C2: 4 x 1 mL 0.35 IU/mL
C3: 4 x 1 mL 0.70 IU/mL
C4: 4 x 1 mL 1.05 IU/mL
C5: 4 x 1 mL 1.40 IU/mL
BIOPHEN™ Arixtra® Calibrator
CE-IVD Arixtra® calibrator plasma set
222501
C1: 3 x 1 mL 0.00 μg/mL
C2: 3 x 1 mL 0.50 μg/mL
C3: 3 x 1 mL 1.00 μg/mL
C4: 3 x 1 mL 1.50 μg/mL
BIOPHEN™ Riva- roxaban Plasma Calibrator
CE-IVD
Riva- roxaban calibrator plasma set, standard range
222701
C1: 4 x 1 mL 50.00 ng/mL
C2: 4 x 1 mL 250.00 ng/mL
C3: 4 x 1 mL 500.00 ng/mL
BIOPHEN™ Riva- roxaban Calibrator Low
CE-IVD
Riva- roxaban calibrator plasma set, low range
226001
CI: 4 x 1 mL 0.00 ng/mL
CII: 4 x 1 mL 50.00 ng/mL
CIII: 4 x 1 mL 100.00 ng/mL
BIOPHEN™ Apixaban Calibrator
CE-IVD
Apixaban calibrator plasma set, standard range
226201
C1: 4 x 1 mL 50.00 ng/mL
C2: 4 x 1 mL 300.00 ng/mL
C3: 4 x 1 mL 600.00 ng/mL
BIOPHEN™ Apixaban Calibrator Low
CE-IVD
Apixaban calibrator plasma set, low range
226101
CI: 4 x 1 mL 0.00 ng/mL
CII: 4 x 1 mL 50.00 ng/mL
CIII: 4 x 1 mL 100.00 ng/mL
EDOXABAN LMVHUFH
BIVALIRUDIN
DABIGATRAN
APIXABAN
ARGATROBAN
RIVADOXABAN
DANAPAROÏD
FONDAPARINUX
ANTICOAGULANTS
EDOXABAN LMVHUFH
BIVALIRUDIN
DABIGATRAN
APIXABAN
ARGATROBAN
RIVADOXABAN
DANAPAROÏD
FONDAPARINUX
ANTICOAGULANTS
Product Name RS
Descrip- tion Ref.
Presenta- tion
Approxi- mative Content
CA LI
BR AT
O RS
BIOPHEN™ Edoxaban Calibrator
CE-IVD
Edoxaban calibrator plasma set, standard range
226501
C1: 4 x 1 mL 0.00 ng/mL
C2: 4 x 1 mL 250.00 ng/mL
C3: 4 x 1 mL 500.00 ng/mL
BIOPHEN™ Edoxaban Calibrator Low
CE-IVD
Edoxaban calibrator plasma set, low range
226401
CI: 4 x 1 mL 0.00 ng/mL
CII: 4 x 1 mL 50.00 ng/mL
CIII: 4 x 1 mL 100.00 ng/mL
BIOPHEN™ Orgaran® Calibrator
CE-IVD Orgaran® calibrator plasma set
222201
C1: 4 x 1 mL 0.00 U/mL
C2: 4 x 1 mL 0.40 U/mL
C3: 4 x 1 mL 0.80 U/mL
C4: 4 x 1 mL 1.20 U/mL
C5: 4 x 1 mL 1.60 U/mL
Argatroban Plasma Calibrator
CE-IVD Argatroban calibrator plasma set
SC030K
C1: 4 x 1 mL 0.00 μg/mL
C2: 4 x 1 mL 0.50 μg/mL
C3: 4 x 1 mL 1.00 μg/mL
C4: 4 x 1 mL 1.50 μg/mL
C5: 4 x 1 mL 2.00 μg/mL
BIOPHEN™ Bivalirudin Calibrator
CE-IVD Bivalirudin calibrator plasma set
226701
C1: 2 x 1 mL 0.00 μg/mL
C2: 2 x 1 mL 1.00 μg/mL
C3: 2 x 1 mL 2.00 μg/mL
C4: 2 x 1 mL 3.50 μg/mL
C5: 2 x 1 mL 5.00 μg/mL
BIOPHEN™ Dabigatran Plasma Calibrator
CE-IVD
Dabigatran calibrator plasma set, standard range
222801
C1: 4 x 1 mL 50.00 ng/mL
C2: 4 x 1 mL 250.00 ng/mL
C3: 4 x 1 mL 500.00 ng/mL
BIOPHEN™ Dabigatran Calibrator Low
CE-IVD
Dabigatran calibrator plasma set, low range
222901
CI: 4 x 1 mL 0.00 ng/mL
CII: 4 x 1 mL 50.00 ng/mL
CIII: 4 x 1 mL 100.00 ng/mL