Siemens Healthcare Diagnostics, a global leader

in clinical diagnostics, provides healthcare

professionals in hospital, reference, and physician
office laboratories and point-of-care settings
with the vital information required to accurately
diagnose, treat, and monitor patients. Our
innovative portfolio of performance-driven
solutions and personalized customer care
combine to streamline workflow, enhance
operational efficiency, and support improved
patient outcomes.
Actin, BCS, BEP, Berichrom, Ci-Trol, Dade,
Data-Fi, Enzygnost, Hepzyme, INNOVANCE,
Innovin, Multifibren, Pathromtin, PFA, ProC,
Thromboclotin, Thromborel, Turbiquant, vWF Ag,
and all associated marks are trademarks of
Siemens Healthcare Diagnostics Inc. Sysmex
is a trademark of Sysmex Corporation. All other
trademarks and brands are the property of their
respective owners.
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regulatory requirements. Please contact
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Order No. A91DX-110902-XC1-4A00
11-2011 | All rights reserved
2011 Siemens Healthcare Diagnostics Inc.

www.siemens.com/diagnostics
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www.siemens.com/diagnostics

Hemostasis Reagents Portfolio

Comprehensive reagent options to power up your lab

Answers for life.

Hemostasis Reagents Portfolio

For more than 30 years, we have held the distinction of being recognized as the global leader in hemostasis testing.
Our comprehensive portfolio of instruments and reagent offerings enables custom-fit solutions to laboratories of all sizes.
Our assays offer a broad selection of various testing solutions to support physicians in making sound diagnostic and therapeutic
decisions. The hemostasis assay portfolio ranges from standard PT and APTT testing to the breakthrough von Willebrand Factor
activity testing technology found in our INNOVANCE VWF Ac Assay. No matter how routine or specialized your testing may be,
we have the solutions to ensure quality testing, standardize results, and offer solutions to meet the needs of your laboratory.
Instrument Availability
Systems and Analyzers
Reagent Name

Reagent Description

Thromborel S Reagent

Thromborel S Reagent is prepared from human placental tissue factor combined with calcium chloride and stabilizers.
The reagent contains minimal residual clotting factors, such as prothrombin or factors VII or X, for clear definition of
factor deficiencies and steep factor assay curves. Because of its high sensitivity to these coagulation factors, the reagent
is suitable for monitoring oral anticoagulant therapy.

Package
Size

OUHP29
OUHP49

10 x 4 mL
10 x 10 mL

B4212-40
B4212-50
B4212-100

10 x 4 mL
10 x 10 mL
12 x 20 mL

Thromborel S Reagent exhibits good correlation with the WHO international reference thromboplastin preparation.
With the Thromborel S Reagent and the appropriate deficient plasma, it is possible to determine activity of coagulation
factors II, V, VII, and X. The reagent differentiates abnormal plasmas, even in the mildly pathological range.

PT
APTT
Fibrinogen
Thrombin Time/
Batroxobin Time

Catalog
No.

BCS
BCS XP

BCT

BFT II

Dade Innovin Reagent

Dade Innovin Reagent is prepared from purified recombinant human tissue factor produced in E. coli, combined with
synthetic phospholipids, calcium, buffers, and stabilizers. It is highly sensitive to extrinsic factor deficiencies and oral
anticoagulant-treated patient plasma samples. The sensitivity of Dade Innovin Reagent is very similar to that of the WHO
human brain reference thromboplastin. It is insensitive to therapeutic levels of heparin, which, in combination with high
sensitivity to coagulation factors, makes Dade Innovin Reagent ideal for monitoring oral anticoagulant therapy and
differentiating abnormal plasmas, even in the mildly pathological range.

Dade Actin Activated

Cephaloplastin Reagent

Dade Actin Activated Cephaloplastin Reagent has moderate sensitivity to factor deficiencies (VIII, IX, XI, and XII) in the
intrinsic system. It is the ideal choice for institutions requiring a moderate screening APTT reagent for routine testing.
Dade Actin has low heparin sensitivity, allowing the monitoring of heparin therapy even with high heparin dosage.
Dade Actin Reagent has moderate sensitivity to lupus anticoagulants.

B4218-1
B4218-2

10 x 2 mL
10 x 10 mL

Dade Actin FS Activated

PTT Reagent

Dade Actin FS Activated PTT Reagent is a highly sensitive reagent for the detection of factor deficiencies (VIII, IX, XI, XII)
of the intrinsic system. With moderate sensitivity to lupus anticoagulants and high sensitivity to heparin, it fulfills all
requirements of routine coagulation testing.

B4218-20
B4218-100

10 x 2 mL
10 x 10 mL

Dade Actin FSL

Activated PTT Reagent

Dade Actin FSL Activated PTT Reagent exhibits increased sensitivity to lupus anticoagulants and moderate heparin
sensitivity. The reagent shows good factor sensitivity to detect clinically significant deficiencies of the intrinsic system.

B4219-1
B4219-2

10 x 2 mL
10 x 10 mL

Pathromtin SL Reagent

Pathromtin SL Reagent exhibits high sensitivity to lupus anticoagulants, factor deficiencies, and heparin.

OQGS29
OQGS35

10 x 5 mL
20 x 5 mL

Multifibren U Reagent

Multifibren U Reagent is a bovine thrombin reagent used in the modified Clauss determination of fibrinogen for the
detection of hereditary or acquired hypo- and hyperfibrinogenemia and dysfibrinogenemia. The reagent is insensitive to
heparin up to 2.0 U/mL and has a wide measuring range of 0.8012.00 g/L.

OWZG19
OWZG23

10 x 2 mL
10 x 5 mL

Dade Thrombin Reagent

Dade Thrombin Reagent is an effective reagent for use in the determination (Clauss method) of fibrinogen in the
detection of hereditary or acquired hypo- and hyperfibrinogenemia, dysfibrinogenemia, and afibrinogenemia.
The reagent offers long stability after reconstitution.

B4233-25
B4233-27

10 x 1 mL
10 x 5 mL

Dade Fibrinogen
Determination Reagent

The Dade Fibrinogen Determination Reagent consists of Dade Thrombin Reagent, Fibrinogen Standard, and Dade
Owrens Veronal Buffer for use in the determination of fibrinogen (Clauss method) in the detection of hereditary or
acquired hypo- and hyperfibrinogenemia, dysfibrinogenemia, and afibrinogenemia. The reagent offers long stability
after reconstitution.

B423315SY

Kit

BC Thrombin Reagent

BC Thrombin Reagent is utilized for the determination of the thrombin time. The BC Thrombin Reagent is suitable for
monitoring of fibrinolytic therapy, screening for disorders of fibrin formation, in suspected cases of severe fibrinogen
deficiency states, and for differentiation between heparin-induced prolongation of the thrombin time and disorders of
fibrinogen formation.

OWNA11

Kit

281007

10 x 10 mL

Thrombin time is found to be prolonged not only due to disorders in fibrin polymerization, but also due to the presence
of heparin. Differentiation can be achieved using Batroxobin Reagent.

Thromboclotin Reagent

Thromboclotin Reagent is intended for the determination of thrombin time in citrated human plasma. The reagent is
suitable for monitoring of fibrinolytic therapy, screening for disorders of fibrin formation, in suspected cases of severe
fibrinogen deficiency states, and for differentiation between heparin-induced prolongation of the thrombin time and
disorders of fibrinogen formation.

Sysmex Systems

CA-7000 CA-1500 CA-560

CS-2000i
CS-2100i

Comments

Thrombin time is found to be prolonged not only due to disorders in fibrin polymerization, but also due to the presence
of heparin. Differentiation can be achieved using Batroxobin Reagent.

Instrument Availability

von Willebrand Factors

Single Factors

Thrombin Time/
Batroxobin Time

Systems and Analyzers

Reagent Name

Reagent Description

Test Thrombin Reagent

Test Thrombin Reagent is intended for the determination of thrombin time in citrated human plasma. The reagent is
suitable for monitoring of fibrinolytic therapy, screening for disorders of fibrin formation, in suspected cases of severe
fibrinogen deficiency states, and for differentiation between heparin-induced prolongation of the thrombin time and
disorders of fibrinogen formation.

Catalog
No.

Package
Size

OWHM13

10 x 5 mL

Thrombin time is found to be prolonged not only due to disorders in fibrin polymerization, but also due to the presence
of heparin. Differentiation can be achieved using Batroxobin Reagent.

BCS
BCS XP

BCT

BFT II

Sysmex Systems
CA-7000 CA-1500 CA-560

CS-2000i
CS-2100i

Comments

Batroxobin Reagent

Batroxobin Reagent is a snake venom-based reagent intended for the determination of the batroxobin time. It is
ideal for monitoring fibrinolytic therapy by determination of fibrinogen/fibrin degradation products, diagnosis of
afibrinogenemia and dysfibrinogenemia, and elucidation of prolonged thrombin times in cases of suspected presence
of heparin.

OUOV21

2 x 5 mL

Coagulation Factor II
Deficient Plasma

Coagulation Factor II Deficient Plasma is a human plasma-based reagent for the detection of hereditary or acquired
deficiencies of factor II (prothrombin). It is manufactured by immunoabsorption and contains a residual factor concentration
of <1% prothrombin and normal levels of fibrinogen and other extrinsic clotting factors. Coagulation Factor II Deficient
Plasma was designed to be used in combination with Dade Innovin or Thromborel S Reagents.

OSGR13

3 x 1 mL

Coagulation Factor V
Deficient Plasma

Coagulation Factor V Deficient Plasma is a human plasma-based reagent for the detection of hereditary or acquired
deficiencies of factor V. It is manufactured by immunoabsorption and contains a residual factor concentration of
<1% factor V and normal levels of fibrinogen and other extrinsic clotting factors. Coagulation Factor V Deficient Plasma
was designed to be used in combination with Dade Innovin or Thromborel S Reagents.

ORSM19

8 x 1 mL

Coagulation Factor VII

Deficient Plasma

Coagulation Factor VII Deficient Plasma is a human plasma-based reagent for the detection of hereditary or acquired
deficiencies of factor VII. It is manufactured by immunoabsorption and contains a residual factor concentration of
<1% factor VII and normal levels of fibrinogen and other extrinsic clotting factors. Coagulation Factor VII Deficient Plasma
was designed to be used in combination with Dade Innovin or Thromborel S Reagents.

OTXV13

3 x 1 mL

Coagulation Factor VIII

Deficient Plasma

Coagulation Factor VIII Deficient Plasma is a lyophilized reagent immunoabsorbed from human plasma. It contains
< 1% residual factor VIII and normal levels of fibrinogen and other intrinsic coagulation factors. It is used for the
determination of factor VIII activity in the diagnosis of congenital and acquired deficiencies of factor VIII.

OTXW17

8 x 1 mL

Coagulation Factor IX
Deficient Plasma

Coagulation Factor IX Deficient Plasma is a human plasma-based reagent for the detection of hereditary or acquired
deficiencies of factor IX (hemophilia B). With a residual factor concentration of <1%, the reagent is ideal for the
monitoring of substitution therapy. Coagulation Factor IX Deficient Plasma was designed to be used in combination
with Dade Actin, Dade Actin FS, Dade Actin FSL, or Pathromtin SL Reagents.

OTXX17

8 x 1 mL

Coagulation Factor X
Deficient Plasma

Coagulation Factor X Deficient Plasma is a human plasma-based reagent for the detection of hereditary or acquired
deficiencies of factor X. It is manufactured by immunoabsorption and contains a residual factor concentration of
<1% factor X and normal levels of fibrinogen and other extrinsic clotting factors. Coagulation Factor X Deficient Plasma
was designed to be used in combination with Dade Innovin or Thromborel S Reagents.

OTXY13

3 x 1 mL

Coagulation Factor XI
Deficient Plasma

Coagulation Factor XI Deficient Plasma is a human plasma-based reagent for the detection of hereditary or acquired
deficiencies of factor XI. The reagent has a residual factor concentration of <1% factor XI and was designed to be used
in combination with Dade Actin, Dade Actin FS, Dade Actin FSL, or Pathromtin SL Reagents.

OSDF13

3 x 1 mL

Coagulation Factor XII

Deficient Plasma

Coagulation Factor XII Deficient Plasma is a human plasma-based reagent for the detection of hereditary or acquired
deficiencies of factor XII. The reagent has a residual factor concentration of <1% factor XII and was designed to be used
in combination with Dade Actin, Dade Actin FS, Dade Actin FSL, or Pathromtin SL Reagents.

OSDG13

3 x 1 mL

Berichrom
Factor XIII Kit

The Berichrom Factor XIII Kit is a chromogenic, quantitative assay for the detection of hereditary or acquired factor XIII
deficiencies. The chromogenic activity reagent is also utilized for the monitoring of patients undergoing factor XIII
substitution therapy.

OWSU11

Kit

Factor VIII
Chromogenic Assay

The Factor VIII Chromogenic Assay is recommended for factor FVIII determination in therapeutic factor FVIII preparations
and the detection of hereditary or acquired factor VIII deficiencies. The chromogenic method is insensitive to heparin at
levels of <10 IU/mL.

B4238-40

Kit

INNOVANCE VWF Ac Kit

The INNOVANCE VWF Kit is a sensitive, reliable, and convenient test system for direct determination of VWF activity.
It employs an advanced new technology, allowing the assay to mimic the way in which VWF binds to glycoprotein
Ib (GPIb) the reaction, the major VWF receptor protein on platelets. Latex particles are coated with an antibody against
GPIb, to which recombinant GPIb is added. The addition of patient plasma induces a VWF-dependent agglutination,
which is detected turbidimetrically. Because the recombinant receptor protein includes two gain-of-function mutations,
the assay does not require ristocetin.

OPHL03

Kit

BC von Willebrand
Reagent

BC von Willebrand Reagent provides a simple, rapid, and automated procedure for the determination of the ristocetin
cofactor activity of von Willebrand factor. The reagent, which provides a rapid measurement time of 250 seconds,
is sensitive to types 1, 2, and 3 of von Willebrand disease (except VWD 2N) and is the recommended screening method
for von Willebrand disease.

OUBD37

5 x 4 mL

von Willebrand Reagent

von Willebrand Reagent is a manual, quantitative activity method sensitive to types 1, 2, and 3 of von Willebrand
disease (except VWD 2N). The ristocetin cofactor assay is recommended for the screening of von Willebrand disease.

OUBD23

5 x 2 mL

vWF Ag Kit

vWF Ag Kit contains is a quantitative, automated immunoassay used to determine the differentiation of quantitative
versus qualitative von Willebrand factor deficiencies. It is sensitive to types 1 and 3 VWF deficiencies and offers a wide
measuring range of 2600%.

OPAB03

Kit

manual method

Instrument Availability

D-Dimer

Fibrinolysis

Heparin

Thrombophilia

Systems and Analyzers

Catalog
No.

Package
Size

BCS
BCS XP

BCT

BFT II

Sysmex Systems

Reagent Description

LA 1 Screening Reagent

LA 1 Screening Reagent contains dilute Russells viper venom and low phospholipids for use in the simplified DRVVT as
a screening test for lupus anticoagulants. The LA 1 Screening Reagent was designed to be used in conjunction with the
LA 2 Confirmation Reagent.

OQGP17

10 x 2 mL

LA 2 Confirmation
Reagent

LA 2 Confirmation Reagent is a simplified dilute Russells viper venom test rich in phospholipids, making it ideal for the
confirmation of lupus anticoagulants. The LA 2 Confirmation Reagent was designed to be used in conjunction with the
LA 1 Screening Reagent.

OQGR13

10 x 1 mL

ProC Global Kit

ProC Global Kit is a coagulometric screening reagent for the protein C pathway. It provides a determination of the
anticoagulatory capacity of the protein C system. The heparin-insensitive reagent is useful in screening individuals
affected by thrombophilia. ProC Global Kit is sensitive to deficiencies of factor V Leiden and proteins C and S, certain
lupus anticoagulants, and high factor VIII levels.

OQLS13

Kit

ProC Ac R Kit

The ProC Ac R Kit, a dilute Russells viper venom test with a sensitivity and specificity of >99%, screens for APC resistance
due to the presence of factor V Leiden in patient samples. The reagent is insensitive to heparin and is not influenced by
high levels of factor VIII.

OPBC03

Kit

Protein C Reagent

Protein C Reagent is a coagulometric reagent used for the quantitative determination of protein C activity.
The reagent is suitable for the detection of hereditary or acquired protein C deficiencies.

OQYG11

Kit

Protein S Ac Reagent

Protein S Ac Reagent, a coagulometric activity reagent, is utilized for the detection of hereditary or acquired
protein S deficiencies.

OPAP03

Kit

Berichrom Protein C Kit

The Berichrom Protein C Kit, a chromogenic activity assay, is utilized for the detection of hereditary or acquired
protein C deficiency types. The assay is also used for the monitoring of substitution therapy with protein C concentrates
in congenital protein C deficiency. The Berichrom Protein C Kit is less susceptible to interfering substances than a
clotting assay.

OUVV15
OUVV17

Kit

INNOVANCE
Antithrombin Kit

The INNOVANCE Antithrombin Kit is an automated chromogenic assay for the quantitative determination of functional
antithrombin. The human factor Xa-based reagent has minimal interference with heparin cofactor II and thrombin
inhibitors such as hirudin. The ready-to-use, liquid reagents provide excellent precision and reliability.

OPFH03
OPFH05

Small Kit
Large Kit

Berichrom
Antithrombin III (A) Kit

The Berichrom Antithrombin III (A) Kit is a chromogenic activity assay for the detection of hereditary or acquired
antithrombin deficiency and monitoring of patients undergoing substitution therapy. The heparin co-factor-independent
lyophilized reagent uses bovine thrombin and exhibits no interference with anti-FXa anticoagulants
(e.g., rivaroxaban).

OWWR17
OWWR15

Small Kit
Large Kit

Berichrom Heparin Kit

The Berichrom Heparin Kit, a chromogenic, factor Xa-based activity assay, is utilized for the monitoring of heparin
therapy and the determination of unfractionated (UF) and low molecular weight (LMW) heparin in patient samples.
The reagent is not influenced by platelet factor IV complexing of heparin and offers a detection limit of 0.05 IU/mL
in UF heparin.

OWLD11

Berichrom
2-Antiplasmin Kit

The Berichrom 2-Antiplasmin Kit is utilized for the determination of 2-antiplasmin and the detection of hereditary
or acquired 2-antiplasmin deficiencies.

Berichrom
Plasminogen Kit

CA-7000 CA-1500 CA-560

CS-2000i
CS-2100i

Reagent Name

Comments

Kit

OUBU15

Kit

Berichrom Plasminogen Kit, a chromogenic activity test system, is used for the determination of plasminogen and the
detection of hereditary or acquired plasminogen deficiencies.

OUCA17

Kit

Berichrom PAI Kit

The Berichrom PAI Kit is a chromogenic test system for the determination of PAI (Plasminogen Activator Inhibitor) levels
as an indicator of a thrombophilic state and hypofibrinolysis. The reagent is not influenced by 2-antiplasmin or FDP.

OWOA15

Kit

INNOVANCE D-Dimer Kit

The INNOVANCE D-Dimer Kit is a rapid, highly precise, and sensitive test system for the determination of D-dimer.
It offers high diagnostic sensitivity of >98% for exclusion of VTE (venous thromboembolism). With its extended assay
range, D-dimer levels can be used for the diagnosis and monitoring of patients with disseminated intravascular
coagulopathy (DIC), as well as for the monitoring of anticoagulation treatment and pregnancy-related coagulopathies
(e.g., pre-eclampsia and HELLP syndrome).

OPBP03
OPBP07

150-Tests Kit
300-Tests Kit

Dade Dimertest
Latex Assay

The Dade Dimertest Latex Assay is a rapid agglutination test system using latex particles coated with a specific D-dimer
monoclonal antibody. Dimertest is intended for the qualitative or semi-quantitative evaluation of cross-linked fibrin
degradation products containing D-dimers.

B4233-60

Kit

manual method

D-Dimer Latex Beads

D-Dimer Latex Beads are latex particles coated with a specific D-dimer monoclonal antibody used in the qualitative or
semi-quantitative evaluation of cross-linked fibrin degradation products containing D-dimers.

B4233-61

1 x 2 mL

manual method

Instrument Availability

Other

Systems and Analyzers

Catalog
No.

Package
Size

BCS
BCS XP

BCT

BFT II

Sysmex Systems
CA-7000 CA-1500 CA-560

CS-2000i
CS-2100i

Comments

Reagent Name

Reagent Description

Enzygnost TAT
micro Kit

The Enzygnost TAT micro is an ELISA assay for thrombin-antithrombin complex determination. The reagent is utilized
for the diagnosis of hypercoagulability (e.g., in DIC).

OWMG15

Kit

ELISA/BEP Systems

Enzygnost F1+2
(monoclonal) Kit

The Enzygnost F1+2 (monoclonal) is an ELISA assay for prothrombin fragment 1 and 2 determination. The reagent is
utilized for the diagnosis of hyper- and hypocoagulable states on BEP Systems.

OPBD03

Kit

ELISA/BEP Systems

Complement Reagents

The Complement Reagent Kit is a functional-activity assay for the determination of total complement. It is useful in the
diagnosis of hereditary and acquired defects of the complement system and for monitoring response to treatment.

OWZD11

Kit

Berichrom
C1-Inhibitor Kit

The Berichrom C1-Inhibitor Kit, a human C1 esterase-based assay, determines the presence of C1 inhibitors in patient
samples. The reagent offers a fast turnaround time-to-result of <10 minutes and detects hereditary or acquired
deficiencies of the C1 inhibitor (e.g., in angioneurotic edema). This chromogenic activity reagent is used for the
diagnosis of angioneurotic edema and for monitoring substitution or steroid therapy in angioneurotic edema.

OUIA15

Kit

INNOVANCE ETP Kit

The INNOVANCE ETP Kit is a global hemostasis-function test system to assess endogenous thrombin potential (ETP).
Several parameters are commonly used to describe ETP, from which the area under the curve (AUC) and peak height
(Cmax) have been shown to be of diagnostic relevance:

OPGA

2 x 50
Tests

ORHO37

10 x 15 mL

Increased AUC has been demonstrated to correlate with an increased risk for recurrent venous thrombosis after
discontinuation of anticoagulation.
Increased AUC and Cmax have been observed due to prothrombin mutation G20210A.
AUC and Cmax are known to be decreased under anticoagulant treatment with vitamin K antagonists.

Standards and Calibrators

Platelets

Supplementary

Reduction of AUC and Cmax have been demonstrated during treatment with argatroban
(direct thrombin inhibitor).

Calcium Chloride Solution

Calcium Chloride Solution is used as a supplementary reagent for various coagulation tests.

Dade Hepzyme Reagent

Dade Hepzyme Reagent is used as a heparin neutralizer in plasma to rule out heparin contamination in coagulation testing.

B4240-10

10 x 1 mL

Owrens Veronal Buffer

Owrens Veronal Buffer is a dilution buffer for coagulation testing.

B4234-25

10 x 15 mL

INNOVANCE
D-Dimer Diluent

INNOVANCE D-Dimer Diluent is a liquid used for dilution of samples with elevated D-dimer concentrations when running
the INNOVANCE D-Dimer Assay.

OPBR03

10 x 5 mL

Imidazole
Buffer Solution

Imidazole Buffer Solution is used as a supplementary reagent for various coagulation assays run on the BCT and
BFT II Systems.

OQAA33

6 x 15 mL

Kaolin Suspension

Kaolin Suspension is used as a supplementary reagent for various assays for the BFT II System.

OQAB42

1 x 50 mL

INNOVANCE PFA
P2Y Cartridges

INNOVANCE PFA P2Y is an easy and reliable test for the detection of P2Y12 receptor blockade in patients undergoing
therapy with a P2Y12 receptor blockade antagonist.

B4170-22

1 x 20
Cartridges

Dade PFA Collagen/EPI

Test Cartridges

The Dade PFA Collagen/EPI Test Cartridge is used for the detection of platelet dysfunction; screening for intrinsic
platelet defects, von Willebrand disease, or exposure to platelet inhibiting agents; presurgical screening for bleeding
risk; and monitoring of aspirin effect and DDAVP. It is sensitive to all types of von Willebrand disease (except 2N),
hereditary platelet defects, low platelet count (<150,000/L), and to aspirin and anti-GP IIb/IIIa antagonists.

B4170-21A

1 x 20
Cartridges

PFA-100 System,
INNOVANCE PFA-200 System

Dade PFA Collagen/ADP

Test Cartridges

The Dade PFA Collagen/ADP Test Cartridges are utilized for the differentiation of aspirin effect on platelets versus
other platelet dysfunctions. It is insensitive to aspirin, yet sensitive to VWD, low platelet counts, and other
platelet dysfunctions.

B4170-21A

1 x 20
Cartridges

PFA-100 System,
INNOVANCE PFA-200 System

Dade PFA Trigger Solution

Dade PFA Trigger Solution is an isotonic buffer solution used for triggering the membrane for cartridges for the PFA Systems.

B4170-50

3 x 11 mL

PFA-100 System,
INNOVANCE PFA-200 System

Dade Cluster Platelet

Aggregation Reagents

Dade Cluster Platelet Aggregation Reagentsconsisting of collagen, ADP, and epinephrineare utilized in platelet
aggregation studies for screening of inherited and acquired platelet dysfunction.

B4236-1

Kit

Standard
Human Plasma

Standard Human Plasma is citrated normal human pooled plasma intended for the calibration of various coagulation
and fibrinolysis assays. Standard human plasma is calibrated against the respective WHO standard, where available.

ORKL17

10 x 1 mL

PT-Multi Calibrator

The PT-Multi Calibrator comprises a set of six plasmas intended for the direct calibration of prothrombin time (PT) in INR
and % of norm. The calibrators are also suitable for the determination of a local ISI value. The single plasma levels have
calibrated values for Innovin and Thromborel S Reagents on each individual instrument.

OPAT03

6 x 1 mL

Fibrinogen
Calibrator Kit

The Fibrinogen Calibrator Kit comprises a set of six plasmasused to prepare reference curves for the fibrinogen assay
by the modified Clauss method using Siemens Healthcare Diagnostics Multifibren U Reagent. (Fibrinogen levels 16
have a range of approximately 0.69.0 g/L.)

OQVK11

6 x 1mL

Berichrom Heparin
UF Calibrator

The Berichrom Heparin UF Calibrator is for use in the preparation of an unfractionated heparin calibration
curve with the Berichrom Heparin Kit. It is calibrated against the fifth WHO standard for unfractionated heparin
(human pooled plasma containing UFH 1.3 U/mL).

OPCC03

6 x 1 mL

Berichrom Heparin
LMW Calibrator

The Berichrom Heparin LMW Calibrator is for use in preparation of a LMW heparin calibration curve with the Berichrom
Heparin Kit. It is calibrated against the second WHO standard for LMWH (human pooled plasma containing LMWH 1.5 U/mL).

OPCA03

6 x 1 mL

PFA-100 System,
INNOVANCE PFA-200 System

manual test

Instrument Availability

Controls

Systems and Analyzers

10

Catalog
No.

Package
Size

BCS
BCS XP

BCT

BFT II

Sysmex Systems
CA-7000 CA-1500 CA-560

CS-2000i
CS-2100i

Reagent Name

Reagent Description

Control Plasma N

Control Plasma N is citrated normal human pooled plasma from selected healthy blood donors. Control Plasma N is used
for the assessment of the precision and analytical deviation of various analytes in the normal range. This control provides
assigned values for the respective available analytes.

ORKE41

10 x 1 mL

Control Plasma P

Control Plasma P is citrated human plasma from selected healthy blood donors. Control Plasma P is a precision and
accuracy control intended to monitor the performance of various parameters in the pathological range. The control
provides assigned values for the respective available analytes.

OUPZ17

10 x 1 mL

Dade Ci-Trol
1, 2, and 3 Controls

Dade Ci-Trol Level 1, 2, and 3 Controls are intended for use as precision and accuracy controls
in the normal, mid, and upper therapeutic ranges for the global assays. The controls provide assigned values for the
respective available analytes.

291070
291071
291072

10 x 1 mL
10 x 1 mL
10 x 1 mL

Dade Ci-Trol
Coagulation Control
Level 1, 2, and 3

Dade Ci-Trol Level 1, 2, and 3 Controls are composed of citrated human pooled plasma from selected healthy blood
donors. They are intended for use as controls in the normal, mid, and upper therapeutic ranges.

B4244-10
B4244-20
B4244-30

20 x 1 mL
20 x 1 mL
20 x 1 mL

V.E.Q. Coag A Control

Global Control consist of citrated normal human pooled plasma from selected healthy blood donors. The control
is utilized for precision control of coagulation tests in the normal range.

291043

10 x 1 mL

V.E.Q. Coag B Control

Global Control consist of citrated human pooled plasma from selected healthy blood donors. The control is utilized for
precision control of coagulation tests in the pathological range.

291044

10 x 1 mL

Dade Data-Fi Abnormal

Fibrinogen Control Plasma

Dade Data-Fi Abnormal Fibrinogen Control Plasma is a control derived from human plasma. It is used to assess accuracy
and precision of Dade Fibrinogen Determination Reagents in the low range.

B4233-22

10 x 1 mL

LA Control Low Control

LA Control Low is a low-positive control for lupus anticoagulant clotting assays using LA 1 Screening and LA 2
Confirmation Reagents.

OQWE11

6 x 1 mL

LA Control High Control

LA Control High is a high-positive control for lupus anticoagulant clotting assays using LA 1 Screening and LA 2
Confirmation Reagents.

OQWD11

6 x 1 mL

ProC Control Plasma

ProC Control Plasma is an assayed intralaboratory control to estimate precision and analytical deviation of the ProC line
of tests in the pathological range.

OQKE17

6 x 1 mL

Ci-Trol Heparin
Control Low

Ci-Trol Heparin Control Low is a low-level control using the activated partial thromboplastin time (APTT).

B4224-50

10 x 1 mL

Ci-Trol Heparin
Control High

Ci-Trol Heparin Control High is a high-level control using the activated partial thromboplastin time (APTT).

B4224-60

10 x 1 mL

INNOVANCE
D-Dimer Controls

INNOVANCE D-Dimer Controls 1 and 2 are assayed controls for the assessment of precision and analytical bias in the
normal and pathological range for the determination of D-dimer with the INNOVANCE D-Dimer Assay.

OPDY03

2 x 5 x for
1 mL

Berichrom Heparin UF
Control 1

Berichrom Heparin UF Control 1 is a precision and accuracy control used to monitor the performance of the Berichrom
Heparin Assay in the therapeutical unfractionated heparin range.

OPBY03

6 x 1 mL

Berichrom Heparin UF
Control 2

Berichrom Heparin UF Control 2 is a precision and accuracy control used to monitor the performance of the Berichrom
Heparin Assay in the subtherapeutical unfractionated heparin range.

OPBZ03

6 x 1 mL

Berichrom Heparin LMW

Control 1

Berichrom Heparin LMW Control is a precision and accuracy control used to monitor the performance of the Berichrom
Heparin Assay in the therapeutical low-molecular-weight heparin range.

OPCD03

6 x 1 mL

Berichrom Heparin LMW

Control 2

Berichrom Heparin LMW Control 2 is a precision and accuracy control used to monitor the performance of the Berichrom
Heparin Assay in the subtherapeutical low-molecular-weight heparin range.

OPCB03

6 x 1 mL

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