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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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Emit® tox Salicylic Acid Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445394
In Commercial Distribution

  • 00842768023347 ()
7S229

  • Salicylate IVD, kit, enzyme immunoassay (EIA)
Emit® tox Acetaminophen Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445384
In Commercial Distribution

  • 00842768023330 ()
7A229

  • Acetaminophen IVD, kit, enzyme immunoassay (EIA)
The Stratus® CS Acute Care(TM) D-dimer assay (DDMR) is an in vitro diagnostic test for the quantitative measurement of cross-linked fibrin degradation products (D-dimer) in human citrated or heparinized plasma on the Stratus® CS analyzer.
Siemens Healthcare Diagnostics Inc.
10701511
In Commercial Distribution

  • 00630414986166 ()
  • 00630414010014 ()
CDDMRE

  • D-dimer IVD, kit, fluorescent immunoassay
The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus cassettes are intended for the semi-quantitative measurement of the following parameters in urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leu
Siemens Healthcare Diagnostics Inc.
10697937
In Commercial Distribution

  • 00630414981147 ()
10697937

  • Urine analyser IVD, laboratory
The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus cassettes are intended for the semi-quantitative measurement of the following parameters in urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leu
Siemens Healthcare Diagnostics Inc.
10494134
In Commercial Distribution

  • 00630414981130 ()
10494134

  • Urine analyser IVD, laboratory
Calibrator O Atellica IM - CAL (2PK) 2 x 2 x 1.0 mL
Siemens Healthcare Diagnostics Inc.
10995516
In Commercial Distribution

  • 00630414598437 ()
  • 00630414190877 ()
10995516

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, calibrator
BR Calibrator Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995515
In Commercial Distribution

  • 00630414598420 ()
  • 00630414190846 ()
10995515

  • Cancer antigen 27-29 (CA27-29) IVD, calibrator
Calibrator E Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995512
In Commercial Distribution

  • 00630414598390 ()
  • 00630414190822 ()
10995512

  • Multiple steroid hormone IVD, calibrator
Calibrator C - Atellica IM - CAL (2PK) 2 x 2 x 5.0mL
Siemens Healthcare Diagnostics Inc.
10995506
In Commercial Distribution

  • 00630414598338 ()
  • 00630414190785 ()
10995506

  • Multiple anaemia-related analyte IVD, calibrator
Homocysteine Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995498
In Commercial Distribution

  • 00630414598253 ()
  • 00630414190730 ()
10995498

  • Homocysteine IVD, calibrator
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