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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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LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays, specifically LA 1 Screening Reagent (DRVVT) and LA 2 Confirmation Reagent (DRVVT) from Siemens Healthcare Diagnostics on automated coagulation analyzers
Siemens Healthcare Diagnostics Products GmbH
10446154
Not in Commercial Distribution

  • 00842768008368 ()
  • 00842768019678 ()
OQWE11

  • Multiple coagulation factor IVD, control
LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays, specifically LA 1 Screening Reagent (DRVVT) and LA 2 Confirmation Reagent (DRVVT) from Siemens Healthcare Diagnostics on automated coagulation analyzers
Siemens Healthcare Diagnostics Products GmbH
10446153
Not in Commercial Distribution

  • 00842768008351 ()
  • 00842768019685 ()
OQWD11

  • Multiple coagulation factor IVD, control
Calibrators for the assay of fibrinogen by the method of Clauss using Multifibren U
Siemens Healthcare Diagnostics Products GmbH
10446148
In Commercial Distribution

  • 00842768008276 ()
OQVK11

  • Fibrinogen assay (factor I) IVD, calibrator
Cleaning solution BN II, BN ProSpec® Systems and BCS® Systems
Siemens Healthcare Diagnostics Products GmbH
10446136
In Commercial Distribution

  • 00842768008153 ()
  • 00842768018930 ()
OQUB21

  • Wash/cleaning solution IVD, automated/semi-automated system
Quantitative determination of ferritin in human serum and heparinized plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446130
In Commercial Distribution

  • 00842768008085 ()
OQTH11

  • Ferritin IVD, kit, nephelometry/turbidimetry
Quantitative determination of IgE in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446129
In Commercial Distribution

  • 00842768008078 ()
  • 00842768018947 ()
OQTG15

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry
Supplementary reagent for multiple protein assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446128
In Commercial Distribution

  • 00842768008061 ()
OQTD11

  • Immunoglobulin removal reagent IVD
Quantitative determination of soluble transferrin receptor (sTfR) in human serum and heparinized plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446127
In Commercial Distribution

  • 00842768008054 ()
  • 00842768018954 ()
OQTC11

  • Soluble transferrin receptor IVD, reagent
Check of the proper functioning and precision of the pipettors on the BCS® System, the BCS® XP System and the BCT System
Siemens Healthcare Diagnostics Products GmbH
10446125
In Commercial Distribution

  • 00842768008023 ()
OQSC11

  • Optical laboratory instrument performance standard calibrator/control IVD, single-use
Cleaning agent for laboratory use
Siemens Healthcare Diagnostics Products GmbH
10446123
In Commercial Distribution

  • 00842768008009 ()
OQRK51

  • Wash/cleaning solution IVD, manual equipment
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