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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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Gamma Glutamyl Transferase Flex® reagent cartridge, 420 tests
Siemens Healthcare Diagnostics Inc.
10445150
In Commercial Distribution

  • 00842768015229 ()
  • 00630414005157 ()
K2045

  • Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry
Cholesterol Flex® reagent cartridge, 600 tests
Siemens Healthcare Diagnostics Inc.
10445143
In Commercial Distribution

  • 00842768015090 ()
  • 00630414005102 ()
K1027

  • Total cholesterol lipid IVD, kit, spectrophotometry
Y-Glutamyl Transferase Flex® reagent cartridge, 288 (4x72) tests
Siemens Healthcare Diagnostics Inc.
10444960
In Commercial Distribution

  • 00842768014154 ()
  • 00630414004433 ()
DF45A

  • Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry
Quantitative determination of ADNase B in human serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446658
In Commercial Distribution

  • 00842768013317 ()
OWTI11

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, reagent
Qualitative detection or semi-quantitative determination of anti-streptolysin O (ASL) in human serum
Siemens Healthcare Diagnostics Products GmbH
10446600
Not in Commercial Distribution

  • 00842768012730 ()
OWHP21

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
The N Cuvette Segments are part of the BN ProSpec system.
Siemens Healthcare Diagnostics Products GmbH
10446539
In Commercial Distribution

  • 00842768012334 ()
  • 00842768024788 ()
OVLK31

  • Laboratory analyser cuvette IVD, single-use
The N Evaporation Cap 5ml is is part of the BN ProSpec system.
Siemens Healthcare Diagnostics Products GmbH
10446535
In Commercial Distribution

  • 00842768012303 ()
  • 00842768024801 ()
OVLC31

  • Nephelometry immunoassay analyser IVD
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
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