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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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RapiTex® CRP - 00842768011078

Qualitative detection or semi-quantitative determination of C-reactive protein (CRP) in human serum
Siemens Healthcare Diagnostics Products GmbH
10446419
In Commercial Distribution

  • 00842768011078 ()
OUAX31

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

RapiTex® RF - 00842768011061

Qualitative detection or semi-quantitative determination of rheumatoid factors (RF) in human serum
Siemens Healthcare Diagnostics Products GmbH
10446418
In Commercial Distribution

  • 00842768011061 ()
OUAT45

  • Rheumatoid factor IVD, kit, agglutination

Coagulation Factor X Deficient Plasma - 00842768011030

For the determination of the activity of coagulation factor X in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10446415
In Commercial Distribution

  • 00842768011030 ()
  • 00842768018817 ()
OTXY13

  • Coagulation factor X IVD, reagent

N Antiserum to Human Transferrin - 00842768009907

Quantitative determination of transferrin in human serum, plasma and urine on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446309
In Commercial Distribution

  • 00842768009907 ()
OSAX15

  • Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry

N Antiserum to Human a1-acid Glycoprotein - 00842768009884

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

N Latex ß2-Microglobulin - 00842768008429

Quantitative determination of ß2-microglobulin in human serum, plasma and urine on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446162
In Commercial Distribution

  • 00842768008429 ()
OQWU21

  • Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry

LA Control High - 00842768008351

LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays, specifically LA 1 Screening Reagent (DRVVT) and LA 2 Confirmation Reagent (DRVVT) from Siemens Healthcare Diagnostics on automated coagulation analyzers
Siemens Healthcare Diagnostics Products GmbH
10446153
Not in Commercial Distribution

  • 00842768008351 ()
  • 00842768019685 ()
OQWD11

  • Multiple coagulation factor IVD, control

Cleaner SCS - 00842768008153

Cleaning solution BN II, BN ProSpec® Systems and BCS® Systems
Siemens Healthcare Diagnostics Products GmbH
10446136
In Commercial Distribution

  • 00842768008153 ()
  • 00842768018930 ()
OQUB21

  • Wash/cleaning solution IVD, automated/semi-automated system

N Latex IgE mono - 00842768008078

Quantitative determination of IgE in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446129
In Commercial Distribution

  • 00842768008078 ()
  • 00842768018947 ()
OQTG15

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry

N Supplementary Reagent L - 00842768008061

Supplementary reagent for multiple protein assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446128
In Commercial Distribution

  • 00842768008061 ()
OQTD11

  • Immunoglobulin removal reagent IVD
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