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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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IMMULITE® Systems ALB CONTROL Albumin - 00630414953106

Albumin - IMMULITE - CTL - 2x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385388
In Commercial Distribution

  • 00630414953106 ()
LHACM

  • Albumin IVD, control

IMMULITE® Systems BMG CONTROL Beta-2 Microglobulin - 00630414952956

B2-MICROGLOBULIN - IMMULITE - CTL - 3x1mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385587
In Commercial Distribution

  • 00630414952956 ()
BMCM

  • Beta-2-microglobulin IVD, control

BCS® XP System - 00630414945514

The Behring Coagulation System (BCS XP System) performs quantitative assays of specific parameters in human citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10459330
In Commercial Distribution

  • 00630414945514 ()
OVOB03

  • Coagulation analyser IVD, laboratory

Coagulation Factor VII Deficient Plasma - 00630414640792

For the determination of the activity of coagulation factor VII in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10873879
In Commercial Distribution

  • 00842768018848 ()
  • 00630414640792 ()
10873879

  • Coagulation factor VII IVD, reagent

Coagulation Factor VIII Deficient Plasma - 00630414640761

For the determination of the activity of coagulation factor VIII in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10873880
In Commercial Distribution

  • 00842768018831 ()
  • 00630414640761 ()
10873880

  • Coagulation factor VIII IVD, reagent

Coagulation Factor V Deficient Plasma - 00630414640754

For the determination of the activity of coagulation factor V in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10873876
In Commercial Distribution

  • 00842768018886 ()
  • 00630414640754 ()
10873876

  • Coagulation factor V IVD, reagent

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

Coagulation Factor II Deficient Plasma - 00630414640686

For the determination of the activity of coagulation factor II (prothrombin) in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10873878
In Commercial Distribution

  • 00842768018855 ()
  • 00630414640686 ()
10873878

  • Coagulation factor II (prothrombin) IVD, reagent
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