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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

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

IMMULITE 2000 rPru av 1 Specific Allergen - 00630414006345

rPru av 1 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10471072
In Commercial Distribution

  • 00630414006345 ()
A597L2

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

IMMULITE 2000 rMal d 4 Specific Allergen - 00630414006291

rMal d 4 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10471077
In Commercial Distribution

  • 00630414006291 ()
A796L2

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

IMMULITE 2000 nPru p 3 Specific Allergen - 00630414006284

nPru p 3 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10368596
In Commercial Distribution

  • 00630414006284 ()
A603L2

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

IMMULITE 2000 rPru av 4 Specific Allergen - 00630414006277

rPru av 4 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10471075
In Commercial Distribution

  • 00630414006277 ()
A600L2

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

IMMULITE 2000 rMal d 1 Specific Allergen - 00630414006246

rMal d 1 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10483381
In Commercial Distribution

  • 00630414006246 ()
A464L2

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

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
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