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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 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 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) Control SY - 00842768007248

Assayed control for Lp(a) assay on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446040
In Commercial Distribution

  • 00842768007248 ()
  • 00842768019104 ()
OQCW05

  • Lipoprotein A IVD, control

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

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
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