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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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RAPIDLab® 348 6.8/7.3 Buffer Pack - 00630414053455

RAPIDLab® 348/348EX 6.8/7.3 Buffer Reagent
Siemens Healthcare Diagnostics Inc.
10309757
In Commercial Distribution

  • 00630414053455 ()
104227

  • Multiple blood gas analyte IVD, calibrator

Ready Sensor™ Lactate Biosensor - 00630414051499

Ready Sensor™ Lactate Biosensor, an in vitro diagnostic medical device for the measurement of lactate in Siemens Healthcare Diagnostics RAPIDLab® Series systems - Single Lactate Warranty Replacement
Siemens Healthcare Diagnostics Inc.
10334138
In Commercial Distribution

  • 00630414051499 ()
102455

  • Lactate electrode IVD

Emit II Plus Specialty Multi Drug Calibrator/Control Level 1 - 00630414028026

Emit II Plus Specialty Multi Drug Calibrator/Control Level 1
Siemens Healthcare Diagnostics Inc.
10720807
In Commercial Distribution

  • 00630414028026 ()
9T529UL

  • Multiple drugs of abuse IVD, calibrator

Dade® Innovin® - 00630414023496

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873568
In Commercial Distribution

  • 00630414023496 ()
  • 00842768019609 ()
B4212-101

  • Prothrombin time (PT) IVD, reagent

Dade® Innovin® - 00630414023489

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873567
In Commercial Distribution

  • 00630414023489 ()
  • 00842768019586 ()
B4212-51

  • Prothrombin time (PT) IVD, reagent

Dade® Innovin® - 00630414023472

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873566
In Commercial Distribution

  • 00630414023472 ()
  • 00842768019593 ()
B4212-41

  • Prothrombin time (PT) IVD, reagent

Thromborel® S - 00630414023441

Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X
Siemens Healthcare Diagnostics Products GmbH
10873564
Not in Commercial Distribution

  • 00630414023441 ()
  • 00842768018756 ()
OUHP31

  • Prothrombin time (PT) IVD, kit, clotting

ADVIA Centaur® AFP - 00630414022963

Alpha-Fetoprotein (AFP) Assay Kit (1-pack) 100T
Siemens Healthcare Diagnostics Inc.
10998577
Not in Commercial Distribution

  • 00630414022963 ()
10998577

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

ADVIA 2120i wthout Autosampler - 00630414019796

ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITHOUT AUTOSAMPLER
Siemens Healthcare Diagnostics Inc.
11219531
In Commercial Distribution

  • 00630414019796 ()
11219531

  • Haematological cell analyser IVD

ADVIA 2120i with SAA Autosampler - 00630414019789

ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITH SINGLE ASPIRATE
Siemens Healthcare Diagnostics Inc.
11219530
In Commercial Distribution

  • 00630414019789 ()
11219530

  • Haematological cell analyser IVD
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