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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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Control Plasma P - 00630414639703

Assayed control used to monitor the performance of coagulation assays in the pathological range
Siemens Healthcare Diagnostics Products GmbH
10873891
In Commercial Distribution

  • 00842768018589 ()
  • 00630414639703 ()
10873891

  • Multiple coagulation factor IVD, control

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

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 Systems Herpes I and II IgG - 00630414999784

IMMULITE® 2000 Systems Herpes I and II IgG
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381333
In Commercial Distribution

  • 00630414999784 ()
L2KHVG6

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
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