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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Dade Owren's Veronal Buffer - 00630414640273

Dilution buffer for coagulation testing
Siemens Healthcare Diagnostics Products GmbH
10873839
In Commercial Distribution

  • 00842768019494 ()
  • 00630414640273 ()
10873839

  • Buffered sample diluent IVD

Dade Thrombin Reagent - 00630414640266

Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies
Siemens Healthcare Diagnostics Products GmbH
10873837
In Commercial Distribution

  • 00842768019517 ()
  • 00630414640266 ()
10873837

  • Fibrinogen assay (factor I) IVD, reagent

Dade Ci-Trol Heparin Control, Low - 00630414640259

Control in heparin assay procedures
Siemens Healthcare Diagnostics Products GmbH
10873833
In Commercial Distribution

  • 00842768019548 ()
  • 00630414640259 ()
10873833

  • Multiple coagulation factor IVD, control

Dade Actin FSL Activated PTT Reagent - 00630414640242

Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10873831
In Commercial Distribution

  • 00842768019555 ()
  • 00630414640242 ()
10873831

  • Activated partial thromboplastin time (APTT) IVD, reagent

INNOVANCE D-Dimer Controls - 00630414640181

INNOVANCE® D-Dimer Control 1 and Control 2 are assayed, normal and pathological level, intralaboratory quality controls for assessment of precision and analytical bias in the quantitative determination of D-dimer on Siemens and Sysmex® Systems
Siemens Healthcare Diagnostics Products GmbH
10873855
In Commercial Distribution

  • 00630414640181 ()
10873855

  • D-dimer IVD, control

Dade Ci-Trol Coagulation Control Level 1 - 00630414640167

For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10873842
In Commercial Distribution

  • 00842768019470 ()
  • 00630414640167 ()
10873842

  • Multiple coagulation factor IVD, control

Dade Data-Fi Abnormal Fibrinogen Control - 00630414640150

Assessment of accuracy and precision of Dade® Fibrinogen Determination Reagents in the low range
Siemens Healthcare Diagnostics Products GmbH
10873836
In Commercial Distribution

  • 00842768019524 ()
  • 00630414640150 ()
10873836

  • Fibrinogen assay (factor I) IVD, control

Dade Fibrinogen Determination Reagents - 00630414640105

Quantitative determination of fibrinogen in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873937
In Commercial Distribution

  • 00630414640105 ()
10873937

  • Fibrinogen assay (factor I) IVD, kit, clotting

LA Control High - 00630414640099

LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays
Siemens Healthcare Diagnostics Products GmbH
10873936
In Commercial Distribution

  • 00842768019685 ()
  • 00630414640099 ()
10873936

  • Lupus anticoagulant marker IVD, control

LA Control Low - 00630414640013

LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays
Siemens Healthcare Diagnostics Products GmbH
10873935
In Commercial Distribution

  • 00842768019678 ()
  • 00630414640013 ()
10873935

  • Lupus anticoagulant marker IVD, control

Dade Innovin - 00630414640006

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873933
In Commercial Distribution

  • 00842768019586 ()
  • 00630414640006 ()
10873933

  • Prothrombin time (PT) IVD, reagent

Thromborel S - 00630414639963

Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X
Siemens Healthcare Diagnostics Products GmbH
10873931
In Commercial Distribution

  • 00842768018749 ()
  • 00630414639963 ()
10873931

  • Prothrombin time (PT) IVD, reagent

INNOVANCE Heparin LMW Control 1 - 00630414639956

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873929
In Commercial Distribution

  • 00630414229539 ()
  • 00630414639956 ()
10873929

  • Heparin anti-Xa IVD, control

INNOVANCE Heparin UF Control 1 - 00630414639949

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873926
In Commercial Distribution

  • 00630414229515 ()
  • 00630414639949 ()
10873926

  • Heparin anti-Xa IVD, control

Dade CA System Buffer - 00630414639901

For coagulation tests and as a rinsing solution for the sample needles of the Sysmex® CA Systems
Siemens Healthcare Diagnostics Products GmbH
10873915
In Commercial Distribution

  • 00842768019845 ()
  • 00630414639901 ()
10873915

  • Buffered sample diluent IVD

Dade Innovin - 00630414639888

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873934
In Commercial Distribution

  • 00842768019609 ()
  • 00630414639888 ()
10873934

  • Prothrombin time (PT) IVD, reagent

Dade Innovin - 00630414639871

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873932
In Commercial Distribution

  • 00842768019593 ()
  • 00630414639871 ()
10873932

  • Prothrombin time (PT) IVD, reagent

INNOVANCE Heparin - 00630414639864

For the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH)
Siemens Healthcare Diagnostics Products GmbH
10873930
In Commercial Distribution

  • 00630414639864 ()
10873930

  • Heparin anti-Xa IVD, kit, chromogenic

INNOVANCE Heparin LMW Control 2 - 00630414639857

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873928
In Commercial Distribution

  • 00630414229546 ()
  • 00630414639857 ()
10873928

  • Heparin anti-Xa IVD, control

INNOVANCE Heparin UF Control 2 - 00630414639840

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873927
In Commercial Distribution

  • 00630414229522 ()
  • 00630414639840 ()
10873927

  • Heparin anti-Xa IVD, control

INNOVANCE Heparin Calibrator - 00630414639833

For calibration of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873925
In Commercial Distribution

  • 00630414639833 ()
10873925

  • Heparin anti-Xa IVD, calibrator

INNOVANCE Free PS Ag - 00630414639826

For the quantitative determination of free protein S antigen in human plasma collected from venous blood samplesin 3.2 % sodium citrate tubes on the BCS XP System, the SYSMEX CS-2500 analyzer and the SYSMEX CS-5100 analyzer.
Siemens Healthcare Diagnostics Products GmbH
10873921
In Commercial Distribution

  • 00630414639826 ()
10873921

  • Protein S IVD, kit, nephelometry/turbidimetry

INNOVANCE Antithrombin - 00630414639796

Chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10873911
In Commercial Distribution

  • 00630414639796 ()
10873911

  • Antithrombin III (ATIII) IVD, kit, chromogenic

Standard Human Plasma - 00630414639772

Standard Human Plasma for the calibration of coagulation and fibrinolysis tests
Siemens Healthcare Diagnostics Products GmbH
10873907
In Commercial Distribution

  • 00842768018893 ()
  • 00630414639772 ()
10873907

  • Multiple coagulation factor IVD, calibrator

LA 1 Screening Reagent - 00630414639765

LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lupus Anticoagulants
Siemens Healthcare Diagnostics Products GmbH
10873904
In Commercial Distribution

  • 00842768019654 ()
  • 00630414639765 ()
10873904

  • Lupus anticoagulant marker IVD, reagent

Factor V Leiden - 00630414639758

Russell Viper Venom-based test for screening of resistance to Activated Protein C (APC) in plasma from individuals with the Factor V (Leiden) defect
Siemens Healthcare Diagnostics Products GmbH
10873903
In Commercial Distribution

  • 00630414639758 ()
10873903

  • Activated protein C resistance ratio (APCR) IVD, kit, clotting

Multifibren U - 00630414639741

Quantitative determination of fibrinogen in plasma
Siemens Healthcare Diagnostics Products GmbH
10873901
In Commercial Distribution

  • 00842768018503 ()
  • 00630414639741 ()
10873901

  • Fibrinogen assay (factor I) IVD, reagent

Multifibren U - 00630414639734

Quantitative determination of fibrinogen in plasma
Siemens Healthcare Diagnostics Products GmbH
10873900
In Commercial Distribution

  • 00842768018541 ()
  • 00630414639734 ()
10873900

  • Fibrinogen assay (factor I) IVD, reagent

Berichrom Protein C - 00630414639710

Quantative determination of protein C activity as an aid in the diagnosis of inherited and acquired deficiencies
Siemens Healthcare Diagnostics Products GmbH
10873893
In Commercial Distribution

  • 00630414639710 ()
10873893

  • Protein C IVD, kit, chromogenic

Control Plasma P - 00630414639703

Assayed control used to monitor the performance of coagulation assays in the pathological range
Siemens Healthcare Diagnostics Products GmbH
10873891
In Commercial Distribution

  • 00842768018589 ()
  • 00630414639703 ()
10873891

  • Multiple coagulation factor IVD, control

INNOVANCE Antithrombin - 00630414639680

Chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10873910
In Commercial Distribution

  • 00630414639680 ()
10873910

  • Antithrombin III (ATIII) IVD, kit, chromogenic

INNOVANCE Antithrombin - 00630414639673

Chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10873909
In Commercial Distribution

  • 00630414639673 ()
10873909

  • Antithrombin III (ATIII) IVD, kit, chromogenic

INNOVANCE® D-Dimer Sample Diluent - 00630414639666

For use in conjunction with INNOVANCE D-Dimer to dilute samples
Siemens Healthcare Diagnostics Products GmbH
10873905
In Commercial Distribution

  • 00842768019265 ()
  • 00630414639666 ()
10873905

  • Buffered sample diluent IVD

Berichrom Antithrombin III (A) - 00630414639659

Determination of the functional activity of antithrombin III (AT III) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873899
In Commercial Distribution

  • 00630414639659 ()
10873899

  • Antithrombin III (ATIII) IVD, kit, chromogenic

Test Thrombin Reagent - 00630414639635

Determination of thrombin time in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873894
In Commercial Distribution

  • 00630414639635 ()
10873894

  • Thrombin time (TT) IVD, kit, clotting

Berichrom Protein C - 00630414639628

Quantative determination of protein C activity as an aid in the diagnosis of inherited and acquired deficiencies
Siemens Healthcare Diagnostics Products GmbH
10873892
In Commercial Distribution

  • 00630414639628 ()
10873892

  • Protein C IVD, kit, chromogenic

Batroxobin Reagent - 00630414639611

Determination of batroxobin time
Siemens Healthcare Diagnostics Products GmbH
10873889
In Commercial Distribution

  • 00842768018725 ()
  • 00630414639611 ()
10873889

  • Reptilase time IVD, reagent

Coagulation Factor XI Deficient Plasma - 00630414639604

For the determination of the activity of coagulation factor XI in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10873883
In Commercial Distribution

  • 00842768018879 ()
  • 00630414639604 ()
10873883

  • Coagulation factor XI IVD, reagent

Coagulation Factor X Deficient Plasma - 00630414639598

For the determination of the activity of coagulation factor X in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10873882
In Commercial Distribution

  • 00842768018817 ()
  • 00630414639598 ()
10873882

  • Coagulation factor X IVD, reagent

INNOVANCE VWF Ac - 00630414639468

For the quantitative determination of von Willenbrand factor (VWF) GPIb-binding activity in human sodium citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10873906
In Commercial Distribution

  • 00630414639468 ()
10873906

  • von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry

LA 2 Confirmation Reagent - 00630414639451

LA 2 Confirmation Reagent. Phospholipid-rich DRVV reagent for the specific correction of Lupus Anticoagulants
Siemens Healthcare Diagnostics Products GmbH
10873902
In Commercial Distribution

  • 00842768019661 ()
  • 00630414639451 ()
10873902

  • Lupus anticoagulant marker IVD, reagent

Berichrom Antithrombin III (A) - 00630414639444

Determination of the functional activity of antithrombin III (AT III) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873898
In Commercial Distribution

  • 00630414639444 ()
10873898

  • Antithrombin III (ATIII) IVD, kit, chromogenic

Berichrom a2-Antiplasmin - 00630414639437

Quantative determination of a2-antiplasmin activity as an aid in the diagnosis of inherited or acquired deficiencies and in management of fibrinolytic therapy
Siemens Healthcare Diagnostics Products GmbH
10873884
In Commercial Distribution

  • 00630414639437 ()
10873884

  • Alpha-2-antiplasmin IVD, kit, chromogenic

Berichrom Plasminogen - 00630414639352

Quantitative determination of plasminogen activity as an aid in the diagnosis and monitoring of fibrinolytic disorders
Siemens Healthcare Diagnostics Products GmbH
10873885
In Commercial Distribution

  • 00630414639352 ()
10873885

  • Plasminogen IVD, kit, chromogenic

Atellica IM HBcT2 - 00630414637877

Atellica IM HBcT2 (REF) 500T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11643118
In Commercial Distribution

  • 00630414637877 ()
11643118

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay

Atellica IM HBcT2 QC - 00630414604336

HBc Total 2 (HBcT2) Atellica IM - CLT 2 x 2 x 7.0mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11200740
In Commercial Distribution

  • 00630414604336 ()
11200740

  • Hepatitis B virus core total antibody IVD, control

Atellica IM HBcT2 - 00630414604138

HBc Total 2 (HBcT2) Atellica IM - RGT 100T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11200739
In Commercial Distribution

  • 00630414604138 ()
11200739

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems CCP Anti-CCP IgG - 00630414601991

CCP IgG Ab - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10718148
In Commercial Distribution

  • 00630414601991 ()
L2KPI2(D)

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay

IMMULITE® Systems PTS Calibration Verification Material PSA - 00630414601946

PSA CVM - IMMULITE – CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10713726
In Commercial Distribution

  • 00630414601946 ()
LPTSCVM

  • Complexed prostate specific antigen (cPSA) IVD, control

IMMULITE® 3RD GEN. PSA CVM - 00630414601939

3rd Generation PSA CVM - IMMULITE – CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10713725
In Commercial Distribution

  • 00630414601939 ()
L3PSCVM

  • Total prostate specific antigen (tPSA) IVD, control
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