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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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Coagulation Factor XI Deficient Plasma - 00842768009976

For the determination of the activity of coagulation factor XI in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10446316
In Commercial Distribution

  • 00842768009976 ()
  • 00842768018879 ()
OSDF13

  • Coagulation factor XI IVD, reagent

N Antiserum to Human Plasminogen - 00842768009952

Quantitative determination of plasminogen in human plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446314
In Commercial Distribution

  • 00842768009952 ()
OSCB09

  • Plasminogen IVD, reagent

N Antiserum to Human Fibrinogen - 00842768009945

Quantitative determination of fibrinogen in human plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446313
In Commercial Distribution

  • 00842768009945 ()
OSCA09

  • Fibrinogen assay (factor I) IVD, kit, clotting

N Antiserum to Human a1-Antitrypsin - 00842768009938

Quantitative determination of a1-antitrypsin in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446312
In Commercial Distribution

  • 00842768009938 ()
OSAZ15

  • Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry

N Antiserum to Human a1-Antitrypsin - 00842768009921

Quantitative determination of a1-antitrypsin in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446311
In Commercial Distribution

  • 00842768009921 ()
OSAZ09

  • Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry

N Antiserum to Human Antithrombin III - 00842768009914

Quantitative determination of antithrombin III in human plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446310
In Commercial Distribution

  • 00842768009914 ()
OSAY09

  • Antithrombin III (ATIII) IVD, reagent

N Antiserum to Human Transferrin - 00842768009907

Quantitative determination of transferrin in human serum, plasma and urine on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446309
In Commercial Distribution

  • 00842768009907 ()
OSAX15

  • Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry

N Antiserum to Human Transferrin - 00842768009891

Quantitative determination of transferrin in human serum, plasma and urine on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446308
In Commercial Distribution

  • 00842768009891 ()
OSAX09

  • Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry

N Antiserum to Human a1-acid Glycoprotein - 00842768009884

Quantitative determination of a1-acid glycoprotein in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446307
In Commercial Distribution

  • 00842768009884 ()
OSAW15

  • Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry

N Antiserum to Human a1-acid Glycoprotein - 00842768009877

Quantitative determination of a1-acid glycoprotein in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446306
In Commercial Distribution

  • 00842768009877 ()
OSAW09

  • Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry

N Antiserum to Human Haptoglobin - 00842768009860

Quantitative determination of haptoglobin in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446305
In Commercial Distribution

  • 00842768009860 ()
OSAV15

  • Haptoglobin IVD, kit, nephelometry/turbidimetry

N Antiserum to Human Haptoglobin - 00842768009853

Quantitative determination of haptoglobin in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446304
In Commercial Distribution

  • 00842768009853 ()
OSAV09

  • Haptoglobin IVD, kit, nephelometry/turbidimetry

N Antisera to Human IgM - 00842768009846

Quantitative determination of IgM in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446303
In Commercial Distribution

  • 00842768009846 ()
OSAT19

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

N Antisera to Human IgM - 00842768009822

Quantitative determination of IgM in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446301
In Commercial Distribution

  • 00842768009822 ()
OSAT11

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

N Antisera to Human IgG - 00842768009808

Quantitative determination of IgG in human serum, plasma and CSF on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446299
In Commercial Distribution

  • 00842768009808 ()
OSAS19

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

N Antisera to Human IgG - 00842768009785

Quantitative determination of IgG in human serum, plasma and CSF on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446297
In Commercial Distribution

  • 00842768009785 ()
OSAS11

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

N Antisera to Human IgA - 00842768009761

Quantitative determination of IgA in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446295
In Commercial Distribution

  • 00842768009761 ()
OSAR19

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

N Antisera to Human IgA - 00842768009747

Quantitative determination of IgA in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446293
In Commercial Distribution

  • 00842768009747 ()
OSAR11

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

N Antiserum to Human C3c - 00842768009723

Quantitative determination of complement C3/C3c in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446291
In Commercial Distribution

  • 00842768009723 ()
OSAP15

  • Complement components C3/C3c IVD, kit, nephelometry/turbidimetry

N Antiserum to Human C3c - 00842768009716

Quantitative determination of complement C3/C3c in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446290
In Commercial Distribution

  • 00842768009716 ()
OSAP09

  • Complement components C3/C3c IVD, kit, nephelometry/turbidimetry

N Antiserum to Human C4 - 00842768009709

Quantitative determination of complement C4 in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446289
In Commercial Distribution

  • 00842768009709 ()
OSAO15

  • Complement components C4/C4c IVD, kit, nephelometry/turbidimetry

N Antiserum to Human C4 - 00842768009693

Quantitative determination of complement C4 in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446288
In Commercial Distribution

  • 00842768009693 ()
OSAO09

  • Complement components C4/C4c IVD, kit, nephelometry/turbidimetry

N Antiserum to Human Apolipoprotein B - 00842768009686

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

N Antiserum to Human Apolipoprotein B - 00842768009679

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

Coagulation Factor V Deficient Plasma - 00842768009525

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

Control Plasma N - 00842768009174

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

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

N Latex ß2-Microglobulin - 00842768008429

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 - 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

LA Control High - 00842768008351

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

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

Cleaner SCS - 00842768008153

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

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

N Latex IgE mono - 00842768008078

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

N Supplementary Reagent L - 00842768008061

Supplementary reagent for multiple protein assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446128
In Commercial Distribution

  • 00842768008061 ()
OQTD11

  • Immunoglobulin removal reagent IVD

N Latex sTfR - 00842768008054

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

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

Neodisher® GK - 00842768008009

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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