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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® Fibrinogen Determination Reagents - 00630414023526

Quantitative determination of fibrinogen in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873571
In Commercial Distribution

  • 00630414023526 ()
B4233-17SY

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

LA Control High - 00630414023519

LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays
Siemens Healthcare Diagnostics Products GmbH
10873570
In Commercial Distribution

  • 00630414023519 ()
  • 00842768019685 ()
OQWD13

  • Lupus anticoagulant marker IVD, control

LA Control Low - 00630414023502

LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays
Siemens Healthcare Diagnostics Products GmbH
10873569
In Commercial Distribution

  • 00630414023502 ()
  • 00842768019678 ()
OQWE13

  • Lupus anticoagulant marker IVD, control

Dade® Innovin® - 00630414023496

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873568
In Commercial Distribution

  • 00630414023496 ()
  • 00842768019609 ()
B4212-101

  • Prothrombin time (PT) IVD, reagent

Dade® Innovin® - 00630414023489

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873567
In Commercial Distribution

  • 00630414023489 ()
  • 00842768019586 ()
B4212-51

  • Prothrombin time (PT) IVD, reagent

Dade® Innovin® - 00630414023472

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873566
In Commercial Distribution

  • 00630414023472 ()
  • 00842768019593 ()
B4212-41

  • Prothrombin time (PT) IVD, reagent

Thromborel® S - 00630414023465

Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X
Siemens Healthcare Diagnostics Products GmbH
10873565
In Commercial Distribution

  • 00630414023465 ()
  • 00842768018749 ()
OUHP53

  • Prothrombin time (PT) IVD, reagent

Thromborel® S - 00630414023441

Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X
Siemens Healthcare Diagnostics Products GmbH
10873564
Not in Commercial Distribution

  • 00630414023441 ()
  • 00842768018756 ()
OUHP31

  • Prothrombin time (PT) IVD, kit, clotting

N Protein Standard SL - 00630414285061

N Protein Standard SL is a multi-analyte calibrator for the establishment of reference curves on the BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873692
In Commercial Distribution

  • 00630414285061 ()
  • 00630414287454 ()
OQIM19

  • Plasma protein IVD, calibrator

N Latex ADNase B (USA) - 00630414285054

Quantitative determination of ADNase B in human serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873691
In Commercial Distribution

  • 00630414285054 ()
OWTI15

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, reagent
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