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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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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

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

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® 2000 TSI - 00630414597188

IMMULITE(R) 2000 TSI Assay
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10876421
In Commercial Distribution

  • 00630414597188 ()
L2KSI2(D)

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, chemiluminescent immunoassay

Dade Actin Activated Cephaloplastin Reagent - 00630414640334

Liquid rabbit brain cephalin with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10873829
In Commercial Distribution

  • 00842768019579 ()
  • 00630414640334 ()
10873829

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade Actin Activated Cephaloplastin Reagent - 00630414640310

Liquid rabbit brain cephalin with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10873827
In Commercial Distribution

  • 00842768019579 ()
  • 00630414640310 ()
10873827

  • Activated partial thromboplastin time (APTT) IVD, reagent

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 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
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