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 Class Implantable

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Quantitative determination of retinol-binding protein in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446494
In Commercial Distribution

  • 00842768011856 ()
OUVO09

  • Retinol binding protein IVD, kit, nephelometry/turbidimetry
Quantitative determination of prealbumin in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446452
In Commercial Distribution

  • 00842768011399 ()
OUIF09

  • Collagen pyridium crosslink IVD, reagent
Qualitative detection or semi-quantitative determination of anti-streptolysin O (ASL) in human serum
Siemens Healthcare Diagnostics Products GmbH
10285410
Not in Commercial Distribution

  • 00842768011092 ()
OUBA31

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
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
Cleaning agent for laboratory use
Siemens Healthcare Diagnostics Products GmbH
10446123
In Commercial Distribution

  • 00842768008009 ()
OQRK51

  • Wash/cleaning solution IVD, manual equipment
Assayed control for IgG, IgA, Transferrin, Albumin, a1-microglobulin and Total protein assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446105
In Commercial Distribution

  • 00842768007859 ()
  • 00842768018961 ()
OQLW15

  • Plasma protein IVD, control
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
CYSC CON L is an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of the CYSC method on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445924
In Commercial Distribution

  • 00842768006388 ()
  • 00842768019371 ()
KC735

  • Plasma protein IVD, control
PROT1 CON M is an assayed, mid-level, intralaboratory, multi-analyte quality control for the assessment of precision and analytical bias on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445920
In Commercial Distribution

  • 00842768006340 ()
  • 00842768019425 ()
KC716

  • Plasma protein IVD, control
For the quantitative measurement of retinol binding protein in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445907
Not in Commercial Distribution

  • 00842768006227 ()
  • 00842768020148 ()
K7066

  • Retinol binding protein IVD, kit, nephelometry/turbidimetry
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