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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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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
Vitamin D total 25(OH) (VitD) QC Kit Atellica IM - CLT 2 x 3 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10995724
In Commercial Distribution

  • 00630414600376 ()
10995724

  • Multiple form 25-hydroxy Vitamin D IVD, control
Vitamin D total 25 (OH) (VitD) Atellica IM Master Curve Material Kit 5 x 2 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995723
In Commercial Distribution

  • 00630414600369 ()
10995723

  • Multiple form 25-hydroxy Vitamin D IVD, control
Vitamin D total 25 (OH) (VitD) Diluent Atellica IM CONS (2PK) 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995721
In Commercial Distribution

  • 00630414600345 ()
  • 00630414007946 ()
10995721

  • Buffered sample diluent IVD
Vitamin D total 25(OH) (VitD) - Atellica IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
10995720
In Commercial Distribution

  • 00630414600338 ()
10995720

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
Vitamin D total 25(OH) (VitD) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995719
In Commercial Distribution

  • 00630414600321 ()
10995719

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
Vitamin B12 (VB12) DTT/REL Atellica IM - CONS
Siemens Healthcare Diagnostics Inc.
10995718
In Commercial Distribution

  • 00630414600314 ()
10995718

  • Vitamin B12 IVD, reagent
Vitamin B12 (VB12) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995717
In Commercial Distribution

  • 00630414600307 ()
10995717

  • Vitamin B12 IVD, control
Vitamin B12 (VB12) Diluent Atellica IM - CONS (2PK) 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995716
In Commercial Distribution

  • 00630414600291 ()
  • 00630414007908 ()
10995716

  • Buffered sample diluent IVD
Vitamin B12 (VB12) Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
10995715
In Commercial Distribution

  • 00630414600284 ()
  • 00630414007892 ()
10995715

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay
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