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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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Quantitative determination of apolipoprotein B in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446287
In Commercial Distribution

  • 00842768009686 ()
OSAN15

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
Quantitative determination of apolipoprotein B in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446286
In Commercial Distribution

  • 00842768009679 ()
OSAN09

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
For the determination of the activity of coagulation factor V in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10446271
In Commercial Distribution

  • 00842768009525 ()
  • 00842768018886 ()
ORSM23

  • Coagulation factor V IVD, reagent
Assayed control used to monitor the performance of coagulation assays in the normal range
Siemens Healthcare Diagnostics Products GmbH
10446235
In Commercial Distribution

  • 00842768009174 ()
  • 00842768018909 ()
ORKE45

  • Multiple coagulation factor IVD, control
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
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
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
Quantitative determination of ß2-microglobulin in human serum, plasma and urine on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446162
In Commercial Distribution

  • 00842768008429 ()
OQWU21

  • Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry
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
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