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

  • 00842768009952 ()
OSCB09

  • Plasminogen IVD, reagent
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
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
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
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
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
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
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
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
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
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
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
Quantitative determination of IgM in human CSF and paired CSF/serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446035
In Commercial Distribution

  • 00842768007194 ()
OQAC11

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
For the quantitative measurement of immunoglobulin M in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445904
In Commercial Distribution

  • 00842768006197 ()
  • 00842768020100 ()
K7058

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
For the quantitative measurement of immunoglobulin A in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445901
In Commercial Distribution

  • 00842768006166 ()
  • 00842768020070 ()
K7052

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
20737771322
In Commercial Distribution

  • 04015630913725 ()
20737771322

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Radial immunodiffusion plate package for Human C-3 (b1c/b1a) with standards
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761055 ()
105511

  • Complement components C3/C3c IVD, antibody
Radial immunodiffusion plate package for Human C-3 (b1c/b1a)
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761054 ()
105411

  • Complement components C3/C3c IVD, antibody
Radial immunodiffusion plate package for human IgM with standards
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761035 ()
103511

  • Total immunoglobulin M (IgM total) IVD, antibody
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