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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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Dimension Vista® a1-Acid Glycoprotein Flex® reagent cartridge - 00842768005985

For the quantitative measurement of a1-acid glycoprotein (Orosomucoid) in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445883
In Commercial Distribution

  • 00842768005985 ()
  • 00842768019869 ()
K7012

  • Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry

Dimension Vista® a1-Microglobulin Flex® reagent cartridge - 00842768005978

For the quantitative measurement of a1-microglobulin in human urine on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445882
Not in Commercial Distribution

  • 00842768005978 ()
  • 00842768019852 ()
K7010

  • Alpha-1-microglobulin IVD, kit, nephelometry/turbidimetry

Dade® Ci-Trol® Coagulation Control Level 3 - 00842768004070

For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10445733
In Commercial Distribution

  • 00842768004070 ()
  • 00842768019456 ()
B4244-30

  • Multiple coagulation factor IVD, control

Dade® Ci-Trol® Coagulation Control Level 2 - 00842768004063

For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10445732
In Commercial Distribution

  • 00842768004063 ()
  • 00842768019463 ()
B4244-20

  • Multiple coagulation factor IVD, control

Dade® Ci-Trol® Coagulation Control Level 1 - 00842768004056

For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10445731
In Commercial Distribution

  • 00842768004056 ()
  • 00842768019470 ()
B4244-10

  • Multiple coagulation factor IVD, control

Dade® Hepzyme® - 00842768004049

Heparin neutralizer in plasma to rule out heparin contamination in coagulation testing
Siemens Healthcare Diagnostics Products GmbH
10445730
In Commercial Distribution

  • 00842768004049 ()
  • 00842768019487 ()
B4240-10

  • Coagulation inhibitory substance neutralization IVD, reagent

Factor VIII Chromogenic Assay - 00842768004032

Determination of Factor VIII (antihemophilic factor) activity in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445729
In Commercial Distribution

  • 00842768004032 ()
B4238-40

  • Coagulation factor VIII IVD, kit, chromogenic

Dade® Cluster® Platelet Aggregation Reagents - 00842768003998

For use in platelet aggregometry studies
Siemens Healthcare Diagnostics Products GmbH
10445725
In Commercial Distribution

  • 00842768003998 ()
B4236-1

  • Platelet aggregation study IVD, kit, nephelometry/turbidimetry

Dade® Owren's Veronal Buffer - 00842768003981

Dilution buffer for coagulation testing
Siemens Healthcare Diagnostics Products GmbH
10445724
In Commercial Distribution

  • 00842768003981 ()
  • 00842768019494 ()
B4234-25

  • Buffered sample diluent IVD

Dade® DIMERTEST® Latex Beads - 00842768003974

For use with DIMERTEST® Latex kit for the rapid qualitative or semiquantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (XL-FDP) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445723
Not in Commercial Distribution

  • 00842768003974 ()
B4233-61L

  • D-dimer IVD, reagent

Dade® DIMERTEST® Latex Assay - 00842768003967

The DIMERTEST® Latex Assay is intended for the rapid qualitative or semiquantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (XL-FDP) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445722
Not in Commercial Distribution

  • 00842768003967 ()
B4233-60

  • D-dimer IVD, kit, agglutination

Dade® Thrombin Reagent - 00842768003950

Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies
Siemens Healthcare Diagnostics Products GmbH
10445721
In Commercial Distribution

  • 00842768003950 ()
  • 00842768019500 ()
B4233-27

  • Fibrinogen assay (factor I) IVD, reagent

Dade® Thrombin Reagent - 00842768003943

Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies
Siemens Healthcare Diagnostics Products GmbH
10445720
In Commercial Distribution

  • 00842768003943 ()
  • 00842768019517 ()
B4233-25

  • Fibrinogen assay (factor I) IVD, reagent

Dade® Data-Fi® Abnormal Fibrinogen Control - 00842768003936

Assessment of accuracy and precision of Dade® Fibrinogen Determination Reagents in the low range
Siemens Healthcare Diagnostics Products GmbH
10445719
In Commercial Distribution

  • 00842768003936 ()
  • 00842768019524 ()
B4233-22

  • Fibrinogen assay (factor I) IVD, control

Dade® Fibrinogen Determination Reagents - 00842768003929

Quantitative determination of fibrinogen in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445718
Not in Commercial Distribution

  • 00842768003929 ()
B4233-15SY

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

Dade® Ci-Trol® Heparin Control, High - 00842768003905

Control in heparin assay procedures
Siemens Healthcare Diagnostics Products GmbH
10445716
In Commercial Distribution

  • 00842768003905 ()
  • 00842768019531 ()
B4224-60

  • Multiple coagulation factor IVD, control

Dade® Ci-Trol® Heparin Control, Low - 00842768003899

Control in heparin assay procedures
Siemens Healthcare Diagnostics Products GmbH
10445715
In Commercial Distribution

  • 00842768003899 ()
  • 00842768019548 ()
B4224-50

  • Multiple coagulation factor IVD, control

Dade® Actin® FSL Activated PTT Reagent - 00842768003882

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
10445714
In Commercial Distribution

  • 00842768003882 ()
  • 00842768019555 ()
B4219-2

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade® Actin® FSL Activated PTT Reagent - 00842768003875

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
10445713
In Commercial Distribution

  • 00842768003875 ()
  • 00842768019555 ()
B4219-1

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade® Actin® FS Activated PTT Reagent - 00842768003868

Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445712
In Commercial Distribution

  • 00842768003868 ()
  • 00842768019562 ()
B4218-20

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade® Actin® Activated Cephaloplastin Reagent - 00842768003851

Liquid rabbit brain cephalin with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445711
In Commercial Distribution

  • 00842768003851 ()
  • 00842768019579 ()
B4218-2

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade® Actin® FS Activated PTT Reagent - 00842768003844

Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445710
In Commercial Distribution

  • 00842768003844 ()
  • 00842768019562 ()
B4218-100

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade® Actin® Activated Cephaloplastin Reagent - 00842768003837

Liquid rabbit brain cephalin with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445709
In Commercial Distribution

  • 00842768003837 ()
  • 00842768019579 ()
B4218-1

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade® Innovin® - 00842768003806

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10445706
Not in Commercial Distribution

  • 00842768003806 ()
  • 00842768019586 ()
B4212-50

  • Prothrombin time (PT) IVD, reagent

Dade® Innovin® - 00842768003790

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10445705
Not in Commercial Distribution

  • 00842768003790 ()
  • 00842768019593 ()
B4212-40

  • Prothrombin time (PT) IVD, reagent

Dade® Innovin® - 00842768003783

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10445704
Not in Commercial Distribution

  • 00842768003783 ()
  • 00842768019609 ()
B4212-100

  • Prothrombin time (PT) IVD, reagent

Dade® PFA Trigger Solution - 00842768003691

To aid in the detection of platelet dysfunction in citrated human whole blood
Siemens Healthcare Diagnostics Products GmbH
10445701
In Commercial Distribution

  • 00842768003691 ()
  • 00842768019791 ()
B4170-50

  • Platelet aggregation study IVD, reagent

Dade® PFA Collagen/ADP Test Cartridge - 00842768003684

To aid in the detection of platelet dysfunction in citrated human whole blood
Siemens Healthcare Diagnostics Products GmbH
10445699
In Commercial Distribution

  • 00842768003684 ()
  • 00842768019784 ()
B4170-21A

  • Platelet aggregation study IVD, reagent

Dade® PFA Collagen/EPI Test Cartridge - 00842768003660

To aid in the detection of platelet dysfunction in citrated human whole blood
Siemens Healthcare Diagnostics Products GmbH
10445697
In Commercial Distribution

  • 00842768003660 ()
  • 00842768019777 ()
B4170-20A

  • Platelet aggregation study IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Food Panel 2 - 00630414960401

Food Panel 2 - IMMULITE - RGT - 40 test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385889
In Commercial Distribution

  • 00630414960401 ()
FP2L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Food Panel 1 - 00630414960371

Food Panel 1 - IMMULITE - RGT - 40 test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385882
In Commercial Distribution

  • 00630414960371 ()
FP1L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Rice - 00630414960357

Rice-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385877
In Commercial Distribution

  • 00630414960357 ()
F9L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Peach - 00630414960340

Peach-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385874
In Commercial Distribution

  • 00630414960340 ()
F95L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Cacao - 00630414960333

Cacao-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385872
In Commercial Distribution

  • 00630414960333 ()
F93L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Banana - 00630414960326

Banana-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385871
In Commercial Distribution

  • 00630414960326 ()
F92L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Corn - 00630414960319

Corn-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385868
In Commercial Distribution

  • 00630414960319 ()
F8L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Lamb - 00630414960302

Lamb-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385865
In Commercial Distribution

  • 00630414960302 ()
F88L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Kiwi Fruit - 00630414960296

Kiwi Fruit -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385861
In Commercial Distribution

  • 00630414960296 ()
F84L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Chicken Meat - 00630414960289

Chicken Meat -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385860
In Commercial Distribution

  • 00630414960289 ()
F83L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Cheese-Mold Type - 00630414960272

Cheese-mold type-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385859
In Commercial Distribution

  • 00630414960272 ()
F82L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
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