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Product Name RS

Descrip- tion Ref.

Presenta- tion

Approxi- mative Content

CO N

TR O

LS

BIOPHEN™ UFH Control Plasma

CE-IVD 510(K)

UFH quality control plasma set

223101 C1: 6 x 1 mL 0.20 IU/mL

C2: 6 x 1 mL 0.50 IU/mL

224101 C1: 12 x 1 mL 0.20 IU/mL

223901 C2: 12 x 1 mL 0.50 IU/mL

BIOPHEN™ LMWH Control Plasma

CE-IVD 510(K)

LMWH quality control plasma set

223001 C3: 6 x 1 mL 0.80 IU/mL

C4: 6 x 1 mL 1.20 IU/mL

223801 C3: 12 x 1 mL 0.80 IU/mL

224201 C4: 12 x 1 mL 1.20 IU/mL

BIOPHEN™ LMWH Control Low

CE-IVD 510(K)

LMWH quality control plasma set, low range

223701 CI: 6 x 1 mL 0.25 IU/mL

CII: 6 x 1 mL 0.50 IU/mL

224301 CI: 12 x 1 mL 0.25 IU/mL

224401 CII: 12 x 1 mL 0.50 IU/mL

BIOPHEN™ Arixtra® Control Plasma

CE-IVD

Arixtra® quality control plasma set

224001 C1: 6 x 1 mL 0.40 µg/mL

C2: 6 x 1 mL 1.20 µg/mL

BIOPHEN™ Riva- roxaban Control Plasma

CE-IVD

Riva- roxaban quality control plasma set, standard range

224501

C1: 6 x 1 mL 100 ng/mL

C2: 6 x 1 mL 300 ng/mL

BIOPHEN™ Riva- roxaban Control Low

CE-IVD

Riva- roxaban quality control plasma set, low range

225101

CI: 6 x 1 mL 25 ng/mL

CII: 6 x 1 mL 75 ng/mL

BIOPHEN™ Apixaban Control

CE-IVD

Apixaban quality control plasma set, standard range

225301

C1: 6 x 1 mL 200 ng/mL

C2: 6 x 1 mL 400 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

CO N

TR O

LS

BIOPHEN™ Apixaban Control Low

CE-IVD

Apixaban quality control plasma set, low range

225201

CI: 6 x 1 mL 25 ng/mL

CII: 6 x 1 mL 75 ng/mL

BIOPHEN™ Edoxaban Control

CE-IVD

Edoxaban quality control plasma set, standard range

225501

C1: 6 x 1 mL 150 ng/mL

C2: 6 x 1 mL 300 ng/mL

BIOPHEN™ Edoxaban Control Low

CE-IVD

Edoxaban quality control plasma set, low range

225401

CI: 6 x 1 mL 25 ng/mL

CII: 6 x 1 mL 75 ng/mL

BIOPHEN™ Orgaran® Control

CE-IVD

Orgaran® quality control plasma set

223501 C1: 6 x 1 mL 0.50 U/mL

C2: 6 x 1 mL 1 U/mL

Argatroban Control Plasma

CE-IVD

Argatroban quality control plasma set

SC035K C1: 6 x 1 mL 0.65 μg/mL

C2: 6 x 1 mL 1.25 μg/mL

BIOPHEN™ Bivalirudin Control

CE-IVD

Bivalirudin quality control plasma set

225701 C1: 3 x 1 mL 1.50 µg/mL

C2: 3 x 1 mL 4 µg/mL

BIOPHEN™ Dabigatran Control Plasma

CE-IVD

Dabigatran quality control plasma set, standard range

224701

C1: 6 x 1 mL 100 ng/mL

C2: 6 x 1 mL 300 ng/mL

BIOPHEN™ Dabigatran Control Low

CE-IVD

Dabigatran quality control plasma set, low range

225001

CI: 6 x 1 mL 25 ng/mL

CII: 6 x 1 mL 75 ng/mL

ANTICOAGULANTS CONTROLS

ANTICOAGULANTS CONTROLS GL

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FI BR

IN OL

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M OS

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AT OR

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RO LS

IN DE

X M

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G AN

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AG UL

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