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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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LA 2 Confirmation Reagent - 00842768007491

LA 2 Confirmation Reagent. Phospholipid-rich DRVV reagent for the specific correction of Lupus Anticoagulants
Siemens Healthcare Diagnostics Products GmbH
10458687
In Commercial Distribution

  • 00842768007491 ()
  • 00842768019661 ()
OQGR11

  • Lupus anticoagulant marker IVD, reagent

LA 1 Screening Reagent - 00842768007477

LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lupus Anticoagulants
Siemens Healthcare Diagnostics Products GmbH
10461887
In Commercial Distribution

  • 00842768007477 ()
  • 00842768019654 ()
OQGP15

  • Lupus anticoagulant marker IVD, reagent

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

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 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
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