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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The Stratus® CS Acute Care™ Beta human Chorionic Gonadotropin method (ßhCG) is an in vitro diagnostic test for the quantitative measurement of the total beta subunit, vis, both the intact hCG dimer and the free ß subunit, of the human chorionic gonadotropin hormone in heparinized plasma.
Siemens Healthcare Diagnostics Inc.
10445060
In Commercial Distribution

  • 00842768004407 ()
  • 00630414009759 ()
CBHCG

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay
Creatine Kinase Flex® reagent cartridge, 800 Tests
Siemens Healthcare Diagnostics Inc.
10464356
In Commercial Distribution

  • 00842768027925 ()
  • 00630414005607 ()
K2038

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
The Stratus® CS STAT Fluorometric Analyzer is a microprocessor controlled instrument that measures analytes in body fluids for in vitro diagnostic use. The instrument is intended for use by trained healthcare professionals in the clinical laboratory and point of care settings and is intended for the measurement of the following analytes: High Sensitivity Troponin-I (CTNI), CK-MB Mass (Creatine kinase. MB) (CKMB), Myoglobin (MYO), NT-proBNP (PBNP), D-dimer (DDMR), CardioPhase hsCRP (High Sensitiv
Siemens Healthcare Diagnostics Inc.
10444834
In Commercial Distribution

  • 00842768024863 ()
758000.901

  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated
The Rapidchem® 744 analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na+ (sodium), K+ (potassium), and Cl- (chloride) or Lithium (Li+) in serum, plasma, whole blood and urine (not applicable for Lithium) samples.
Siemens Healthcare Diagnostics Inc.
10324039
In Commercial Distribution

  • 00630414471112 ()
6254738

  • Ion-selective analyser IVD, semi-automated
CK - ADVIA Chem. - RGT - 4x270 tests
Siemens Healthcare Diagnostics Inc.
10341111
Not in Commercial Distribution

  • 00630414209746 ()
  • 00630414003740 ()
B01-4137-01

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
4 wedges per reagent , 2 reagent, 1100 test per carton
Siemens Healthcare Diagnostics Inc.
10729780
In Commercial Distribution

  • 00630414008943 ()
10729780

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
Creatine Kinase Liquid (CK_L) Atellica CH - RGT 664T
Siemens Healthcare Diagnostics Inc.
11097640
In Commercial Distribution

  • 00630414006642 ()
11097640

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
Urea Nitrogen (UN_c) Atellica CH - RGT 6240T
Siemens Healthcare Diagnostics Inc.
11097593
In Commercial Distribution

  • 00630414596471 ()
11097593

  • Urea IVD, kit, enzyme spectrophotometry
Salicylate (Sal) Atellica CH - RGT 1200T
Siemens Healthcare Diagnostics Inc.
11097523
In Commercial Distribution

  • 00630414595887 ()
11097523

  • Salicylate IVD, kit, enzyme spectrophotometry
UrinaryTotal Protein (UPro) Atellica CH - RGT 1600T
Siemens Healthcare Diagnostics Inc.
11097524
Not in Commercial Distribution

  • 00630414595870 ()
  • 00630414006895 ()
11097524

  • Total protein IVD, kit, enzyme spectrophotometry
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