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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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N Latex IgA - 00842768007200

Quantitative determination of IgA in human CSF and paired CSF/serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446036
In Commercial Distribution

  • 00842768007200 ()
OQAI11

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

N Latex IgM - 00842768007194

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

Kaolin Suspension - 00842768007170

Supplementary Reagent for coagulation tests
Siemens Healthcare Diagnostics Products GmbH
10446033
In Commercial Distribution

  • 00842768007170 ()
OQAB45

  • Fibrinogen assay (factor I) IVD, reagent

Imidazole Buffer Solution - 00842768007163

Imidazole Buffer Solution is used as diluent for various coagulation assays
Siemens Healthcare Diagnostics Products GmbH
10446032
In Commercial Distribution

  • 00842768007163 ()
  • 00842768019135 ()
OQAA33

  • Buffered sample diluent IVD

N Latex RF Kit - 00842768006890

Determination of Rheumatoid Factors (RF) in human serum and plasma on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10445992
In Commercial Distribution

  • 00842768006890 ()
OPCE05

  • Rheumatoid factor IVD, kit, nephelometry/turbidimetry

N Latex RF Kit - 00842768006883

Determination of Rheumatoid factors (RF) in human serum and plasma on the BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10445991
In Commercial Distribution

  • 00842768006883 ()
OPCE03

  • Rheumatoid factor IVD, kit, nephelometry/turbidimetry

Berichrom® Heparin LMW Control 1 - 00842768006876

For use as a low level assayed control for the quantitative measurement of low molecular weight heparin with Berichrom Heparin
Siemens Healthcare Diagnostics Products GmbH
10445990
Not in Commercial Distribution

  • 00842768006876 ()
  • 00842768019180 ()
OPCD03

  • Multiple coagulation factor IVD, control

Berichrom® Heparin UF Calibrator - 00842768006869

For calibration of the Berichrom Heparin assay for measurement of unfractionated heparin
Siemens Healthcare Diagnostics Products GmbH
10445989
Not in Commercial Distribution

  • 00842768006869 ()
  • 00842768019197 ()
OPCC03

  • Heparin anti-Xa IVD, calibrator

Berichrom® Heparin LMW Control 2 - 00842768006852

For use as a high level assayed control for the quantitative measurement of low molecular weight heparin with Berichrom Heparin
Siemens Healthcare Diagnostics Products GmbH
10445988
Not in Commercial Distribution

  • 00842768006852 ()
  • 00842768019203 ()
OPCB03

  • Multiple coagulation factor IVD, control

Berichrom® Heparin LMW Calibrator - 00842768006845

For calibration of the Berichrom Heparin assay for measurement of low molecular weight heparin
Siemens Healthcare Diagnostics Products GmbH
10445987
Not in Commercial Distribution

  • 00842768006845 ()
  • 00842768019210 ()
OPCA03

  • Heparin anti-Xa IVD, calibrator
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