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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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ADVIA® Chemistry Albumin BCP Reagents - 00630414947402

Albumin - ADVIA Chem. - RGT - 4x800
Siemens Healthcare Diagnostics Inc.
10711840
In Commercial Distribution

  • 00630414947402 ()
  • 00630414006031 ()
10711840

  • Albumin IVD, kit, spectrophotometry

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

IMMULITE® 2000 XPi Immunoassay System - 00630414945422

IMMULITE® 2000 XPi Instrument
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10373214
In Commercial Distribution

  • 00630414945422 ()
030002-33

  • Chemiluminescent immunoassay analyser IVD

Atellica IM DHEAS2 (REF) 500T - 00630414652597

Atellica IM DHEAS2 (REF) 500T Atellica IM-REF Reagent (REF RGT)
Siemens Healthcare Diagnostics Inc.
11700159
In Commercial Distribution

  • 00630414321486 ()
  • 00630414652597 ()
11700159

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay

Atellica IM 1600 Analyzer - 00630414650623

Atellica IM 1600 Analyzer (Refurbished)
Siemens Healthcare Diagnostics Inc.
11764888
In Commercial Distribution

  • 00630414650623 ()
11066000

  • Chemiluminescent immunoassay analyser IVD

Atellica IM 1300 Analyzer - 00630414650579

Atellica IM 1300 Analyzer (Refurbished)
Siemens Healthcare Diagnostics Inc.
11764765
In Commercial Distribution

  • 00630414650579 ()
11066001

  • Chemiluminescent immunoassay analyser IVD

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
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