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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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Assayed control for RF, ASL and CRP assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873685
In Commercial Distribution

  • 00630414287423 ()
  • 00630414284996 ()
OQDC17

  • Rheumatoid factor IVD, control
TSH - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11129119
In Commercial Distribution

  • 00630414210841 ()
L2KTS6(D)

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TSH - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11129118
In Commercial Distribution

  • 00630414210834 ()
L2KTS2(D)

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Quantitative determination of fibrinogen in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873571
In Commercial Distribution

  • 00630414023526 ()
B4233-17SY

  • Fibrinogen assay (factor I) IVD, kit, clotting
LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays
Siemens Healthcare Diagnostics Products GmbH
10873570
In Commercial Distribution

  • 00630414023519 ()
  • 00842768019685 ()
OQWD13

  • Lupus anticoagulant marker IVD, control
LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays
Siemens Healthcare Diagnostics Products GmbH
10873569
In Commercial Distribution

  • 00630414023502 ()
  • 00842768019678 ()
OQWE13

  • Lupus anticoagulant marker IVD, control
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
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
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
Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X
Siemens Healthcare Diagnostics Products GmbH
10873565
In Commercial Distribution

  • 00630414023465 ()
  • 00842768018749 ()
OUHP53

  • Prothrombin time (PT) IVD, reagent
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