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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 Protein Standard SL - 00842768007590

N Protein Standard SL is a multi-analyte calibrator for the establishment of reference curves on the Siemens Systems
Siemens Healthcare Diagnostics Products GmbH
10446073
In Commercial Distribution

  • 00842768007590 ()
  • 00842768019050 ()
OQIM13

  • Plasma protein IVD, calibrator

N Latex Lp(a) Reagent - 00842768007552

Quantitative determination of Lp(a) in human serum and heparinized plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446069
In Commercial Distribution

  • 00842768007552 ()
  • 00842768019067 ()
OQHL11

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry

Pathromtin® SL - 00842768007538

Determination of the activated partial thromboplastin time (APTT) in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10446067
In Commercial Distribution

  • 00842768007538 ()
  • 00842768019074 ()
OQGS35

  • Activated partial thromboplastin time (APTT) IVD, reagent

Pathromtin® SL - 00842768007521

Determination of the activated partial thromboplastin time (APTT) in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10446066
In Commercial Distribution

  • 00842768007521 ()
  • 00842768019074 ()
OQGS29

  • Activated partial thromboplastin time (APTT) IVD, reagent

N Antiserum to Human C1-Inhibitor - 00842768007323

Quantitative determination of C1 Inhibitor in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446049
In Commercial Distribution

  • 00842768007323 ()
OQEY09

  • Complement component C1 inhibitor IVD, kit, nephelometry/turbidimetry

N Lp(a) Standard SY - 00842768007224

Calibration of Lp(a) assay on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446038
In Commercial Distribution

  • 00842768007224 ()
  • 00842768019111 ()
OQCV05

  • Lipoprotein A IVD, calibrator

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

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
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