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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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INNOVANCE Antithrombin - 00630414639680

Chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10873910
In Commercial Distribution

  • 00630414639680 ()
10873910

  • Antithrombin III (ATIII) IVD, kit, chromogenic

INNOVANCE Antithrombin - 00630414639673

Chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10873909
In Commercial Distribution

  • 00630414639673 ()
10873909

  • Antithrombin III (ATIII) IVD, kit, chromogenic

INNOVANCE® D-Dimer Sample Diluent - 00630414639666

For use in conjunction with INNOVANCE D-Dimer to dilute samples
Siemens Healthcare Diagnostics Products GmbH
10873905
In Commercial Distribution

  • 00842768019265 ()
  • 00630414639666 ()
10873905

  • Buffered sample diluent IVD

Berichrom Antithrombin III (A) - 00630414639659

Determination of the functional activity of antithrombin III (AT III) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873899
In Commercial Distribution

  • 00630414639659 ()
10873899

  • Antithrombin III (ATIII) IVD, kit, chromogenic

Test Thrombin Reagent - 00630414639635

Determination of thrombin time in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873894
In Commercial Distribution

  • 00630414639635 ()
10873894

  • Thrombin time (TT) IVD, kit, clotting

Berichrom Protein C - 00630414639628

Quantative determination of protein C activity as an aid in the diagnosis of inherited and acquired deficiencies
Siemens Healthcare Diagnostics Products GmbH
10873892
In Commercial Distribution

  • 00630414639628 ()
10873892

  • Protein C IVD, kit, chromogenic

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

LA 2 Confirmation Reagent - 00630414639451

LA 2 Confirmation Reagent. Phospholipid-rich DRVV reagent for the specific correction of Lupus Anticoagulants
Siemens Healthcare Diagnostics Products GmbH
10873902
In Commercial Distribution

  • 00842768019661 ()
  • 00630414639451 ()
10873902

  • Lupus anticoagulant marker IVD, reagent

Atellica CH Billirubin Calibrator (BILI CAL) - 00630414615097

Atellica CH Bilirubin Calibrator (BILI CAL)
Siemens Healthcare Diagnostics Inc.
11537243
In Commercial Distribution

  • 00630414313450 ()
  • 00630414615097 ()
11537243

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Atellica CH Prealbumin (PALB) - 00630414614939

Atellica CH Prealbumin (PALB)
Siemens Healthcare Diagnostics Inc.
11537217
In Commercial Distribution

  • 00630414313412 ()
  • 00630414614939 ()
11537217

  • Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry
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