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 Class Implantable

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Syva® RapidTest d.a.u.® 9 mAMP / OPI / COC / THC / PCP / BZO / BAR / TCA / AMP
Siemens Healthcare Diagnostics Inc.
10445362
Not in Commercial Distribution

  • 00842768001338 ()
  • 00630414013961 ()
6A279UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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 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.
10494134
In Commercial Distribution

  • 00630414981130 ()
10494134

  • Urine analyser IVD, laboratory
ATELLICA IM ELF KIT
Siemens Healthcare Diagnostics Inc.
11208118
In Commercial Distribution

  • 00630414618463 ()
11208118

  • Multiple liver fibrosis marker IVD, kit, chemiluminescent immunoassay
ADVIA CENTAUR ELF KIT
Siemens Healthcare Diagnostics Inc.
11207300
In Commercial Distribution

  • 00630414618128 ()
11207300

  • Multiple liver fibrosis marker IVD, kit, chemiluminescent immunoassay
ATELLICA IM ELF MCM SET
Siemens Healthcare Diagnostics Inc.
11208708
In Commercial Distribution

  • 00630414618111 ()
11208708

  • Multiple liver fibrosis marker IVD, control
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