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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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Enhanced Estradiol 2 Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10492322
In Commercial Distribution

  • 00630414578972 ()
10492322

  • Estradiol (oestradiol) (E2) IVD, control
Estradiol - CENTAUR - CAL - 6x2x2mL
Siemens Healthcare Diagnostics Inc.
10379811
In Commercial Distribution

  • 00630414578491 ()
10379811

  • Multiple steroid hormone IVD, calibrator
Estradiol - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10379810
In Commercial Distribution

  • 00630414578484 ()
10379810

  • Multiple steroid hormone IVD, calibrator
The CLINITEK Status® Connector is intended for use with the CLINITEK Status+ analyzer. The connector allows network connectivity and centralized control of all the satellite Point of Care (POC) CLINITEK Status+ analyzers. The connector communicates with remote Hospital and Laboratory Information Systems (HIS/LIS) and interfaces with Electronic Medical Records (EMR).
Siemens Healthcare Diagnostics Inc.
10376323
In Commercial Distribution

  • 00630414578330 ()
10376323

  • Urine analyser IVD, point-of-care
HBsAgII (HBsII) Assay Kit (1-pack) 200T
Siemens Healthcare Diagnostics Inc.
10492138
In Commercial Distribution

  • 00630414578170 ()
10492138

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
ADVIA 120 Hematology System
Siemens Healthcare Diagnostics Inc.
10360959
In Commercial Distribution

  • 00630414575025 ()
067-A004-14

  • Haematological cell analyser IVD
ADVIA 120 Hematology System
Siemens Healthcare Diagnostics Inc.
10360958
In Commercial Distribution

  • 00630414574868 ()
067-A004-13

  • Haematological cell analyser IVD
The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to use analyzer. It is designed to read only Siemens Healthcare Diagnostics Reagent Strips for Urinalysis and Clinitest® hCG tests. This analyzer is intended for the measurement of the following inurine: Albumin, Bibilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG).
Siemens Healthcare Diagnostics Inc.
10379675
In Commercial Distribution

  • 00630414574639 ()
10379675

  • Urine analyser IVD, point-of-care
HbA1C Kit - ADVIA Chem. - CAL - 2x4x0,5mL
Siemens Healthcare Diagnostics Inc.
10491408
Not in Commercial Distribution

  • 00630414574516 ()
10491408

  • Glycated haemoglobin (HbA1c) IVD, calibrator
CA 19-9 - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10491379
In Commercial Distribution

  • 00630414574257 ()
10491379

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
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