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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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VERSANT HCV Control 2.0 Kit
Siemens Healthcare Diagnostics Inc.
10719668
In Commercial Distribution

  • 00630414000510 ()
10719668

  • Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
VERSANT HCV Amplification 2.0 Kit (LiPA) 100 Test for HCV genotyping
Siemens Healthcare Diagnostics Inc.
10719667
In Commercial Distribution

  • 00630414000503 ()
10719667

  • Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
VERSANT HCV Amplification 2.0 Kit (LiPA) 40 Test for HCV genotyping
Siemens Healthcare Diagnostics Inc.
10719666
In Commercial Distribution

  • 00630414000497 ()
10719666

  • Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The RAPIDComm® program manages the process of sending and receiving data from devices and hospital systems located anywhere in your network.
Siemens Healthcare Diagnostics Inc.
11065134
In Commercial Distribution

  • 00630414000466 ()
11065134

  • Medical equipment clinical data interfacing software
ADVIA® Autoslide Slide Maker Stainer
Siemens Healthcare Diagnostics Inc.
10282178
In Commercial Distribution

  • 00630414000220 ()
085-A002-03

  • Microscope slide maker/stainer IVD
Myoglobin - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10361939
Not in Commercial Distribution

  • 00630414000190 ()
4862455

  • Myoglobin IVD, kit, nephelometry/turbidimetry
HAV IgM - CENTAUR - CONS - 2x2x7mL
Siemens Healthcare Diagnostics Inc.
10309084
In Commercial Distribution

  • 00630414480008 ()
5004800

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
HAV IgM Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10309083
In Commercial Distribution

  • 00630414479996 ()
5004126

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Alcohol / Ammonia Kit - ADVIA Chem. - CAL - 6x3mL
Siemens Healthcare Diagnostics Inc.
10309217
In Commercial Distribution

  • 00630414479286 ()
  • 00630414003047 ()
6549444

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Clinitek AtlasPRO® 12 Reagent PAK for Urine Chemistry for use with Clintek Atlas® Urine Chemistry Analyzer
Siemens Healthcare Diagnostics Inc.
10315660
In Commercial Distribution

  • 00630414479095 ()
5085

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
ISE Reference Electrode - ADVIA Chem. - CONS - 1 Piece
Siemens Healthcare Diagnostics Inc.
10309465
In Commercial Distribution

  • 00630414478654 ()
073-0653-01

  • Reference electrode IVD
RAPIDPoint® 405/500 Measurement Cartridge (400 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 405/500 analyzers.
Siemens Healthcare Diagnostics Inc.
10313971
In Commercial Distribution

  • 00630414477855 ()
130523

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
RAPIDPoint® 405/500 Measurement Cartridge (750 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 405/500 analyzers.
Siemens Healthcare Diagnostics Inc.
10310469
In Commercial Distribution

  • 00630414477848 ()
130522

  • Multiple blood gas analyte IVD, kit, ion-selective electrode (ISE)
RAPIDPoint® 405/500 Measurement Cartridge (400 tests) parameters - pH, pCO2, pO2, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili. For in vitro diagnostic use with RAPIDPoint ® 405/500 systems.
Siemens Healthcare Diagnostics Inc.
10327073
In Commercial Distribution

  • 00630414477831 ()
130521

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
RAPIDPoint® 405/500 Measurement Cartridge (750 tests) - pH, pCO2, pO2, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 405/500 analyzers.
Siemens Healthcare Diagnostics Inc.
10323175
In Commercial Distribution

  • 00630414477824 ()
130520

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
CRP (Wide Range) - ADVIA Chem. - CAL - 6x1mL
Siemens Healthcare Diagnostics Inc.
10313256
In Commercial Distribution

  • 00630414475714 ()
B03-4815-01

  • C-reactive protein (CRP) IVD, calibrator
CRP - ADVIA Chem. - RGT - 2x220 tests
Siemens Healthcare Diagnostics Inc.
10318309
Not in Commercial Distribution

  • 00630414475707 ()
B01-4800-01

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
Special Chemistry Kit - ADVIA Chem. - CAL - 1x5mL
Siemens Healthcare Diagnostics Inc.
10311926
In Commercial Distribution

  • 00630414475677 ()
  • 00630414003450 ()
B03-4821-01

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Lactate - ADVIA Chem. - RGT - 3x100 tests
Siemens Healthcare Diagnostics Inc.
10325776
In Commercial Distribution

  • 00630414475660 ()
  • 00630414003580 ()
B01-4818-01

  • Lactate IVD, kit, spectrophotometry
IBCT - ADVIA Chem. - RGT - 4x100/4x80 tests
Siemens Healthcare Diagnostics Inc.
10309071
In Commercial Distribution

  • 00630414474748 ()
3940010

  • Total iron binding capacity (TIBC) IVD, kit, spectrophotometry
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