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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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Determination of thrombin time in human plasma
Siemens Healthcare Diagnostics Products GmbH
10446598
In Commercial Distribution

  • 00842768012716 ()
OWHM13

  • Thrombin time (TT) IVD, kit, clotting
Quantitative determination of Ig light chains, type lambda in human serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446597
In Commercial Distribution

  • 00842768012709 ()
OWHH13

  • Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry
Quantitative determination of Ig light chains, type kappa in human serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446595
In Commercial Distribution

  • 00842768012686 ()
OWHG13

  • Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry
The cuvettes serve coagulation tests as a reaction vessel.
Siemens Healthcare Diagnostics Products GmbH
10446541
In Commercial Distribution

  • 00842768012358 ()
  • 00842768025006 ()
OVMN11

  • Coagulation analyser IVD, laboratory, semi-automated
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
The N Evaporation Cap 2.5ml is part of the BN ProSpec system.
Siemens Healthcare Diagnostics Products GmbH
10446534
In Commercial Distribution

  • 00842768012297 ()
  • 00842768024795 ()
OVLC21

  • Nephelometry immunoassay analyser IVD
The cuvettes serve coagulation tests as a reaction vessel.
Siemens Healthcare Diagnostics Products GmbH
10446530
In Commercial Distribution

  • 00842768012259 ()
  • 00842768024979 ()
OVKG03

  • Coagulation analyser IVD, laboratory, semi-automated
Quantative determination of protein C activity as an aid in the diagnosis of inherited and acquired deficiencies
Siemens Healthcare Diagnostics Products GmbH
10446499
In Commercial Distribution

  • 00842768011900 ()
OUVV15

  • Protein C IVD, kit, chromogenic
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
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