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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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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

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

Control Plasma N - 00630414640747

Assayed control used to monitor the performance of coagulation assays in the normal range
Siemens Healthcare Diagnostics Products GmbH
10873874
In Commercial Distribution

  • 00842768018909 ()
  • 00630414640747 ()
10873874

  • Multiple coagulation factor IVD, control

Pathromtin SL - 00630414640716

Determination of the activated partial thromboplastin time (APTT) in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873863
In Commercial Distribution

  • 00842768019074 ()
  • 00630414640716 ()
10873863

  • Activated partial thromboplastin time (APTT) IVD, reagent

Pathromtin SL - 00630414640709

Determination of the activated partial thromboplastin time (APTT) in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873862
In Commercial Distribution

  • 00842768019074 ()
  • 00630414640709 ()
10873862

  • Activated partial thromboplastin time (APTT) IVD, reagent
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