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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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Protein C Reagent - 00842768008641

Coagulation test for the quantitative determination of protein C activity in human plasma
Siemens Healthcare Diagnostics Products GmbH
10446185
In Commercial Distribution

  • 00842768008641 ()
OQYG11

  • Protein C IVD, kit, clotting

N AS IgG2 - 00842768008467

Quantitative determination of IgG subclass 2 in human serum on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10446169
In Commercial Distribution

  • 00842768008467 ()
OQXK09

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

N AS IgG1 - 00842768008450

Quantitative determination of IgG subclass 1 in human serum on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10446168
In Commercial Distribution

  • 00842768008450 ()
OQXI09

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

LA Control Low - 00842768008368

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

Fibrinogen Calibrator Kit - 00842768008276

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

N Latex Ferritin - 00842768008085

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

BC Validation Kit - 00842768008023

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

N Latex Cystatin C - 00842768007934

Quantitative determination of cystatin C in human serum and heparinized plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446116
In Commercial Distribution

  • 00842768007934 ()
OQNM13

  • Cystatin C IVD, kit, nephelometry/turbidimetry

N Protein Standard UY - 00842768007835

Calibration of Human a1-microglobulin and cystatin C assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446103
In Commercial Distribution

  • 00842768007835 ()
  • 00842768018978 ()
OQLV09

  • Plasma protein IVD, calibrator

BN II Additive - 00842768007781

Washing Solution (concentrate) for cleaning the cuvettes in the BN II System
Siemens Healthcare Diagnostics Products GmbH
10446098
In Commercial Distribution

  • 00842768007781 ()
  • 00842768018992 ()
OQKY61

  • Buffered wash solution IVD
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