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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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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
For in vitro diagnostics use in the detection of human chorionic gonadotropin (hCG) in urine using the Clinitek Status® analyzer(qualitative)
Siemens Healthcare Diagnostics Inc.
10310618
In Commercial Distribution

  • 00630414473604 ()
1760

  • Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical
ADVIA®120/2120/2120i CSF REAGENT
Siemens Healthcare Diagnostics Inc.
10320459
In Commercial Distribution

  • 00630414473444 ()
T01-4610-01

  • Full blood count IVD, reagent
ADVIA®120/2120/2120i 3-in-1 TESTpoint™ High Control
Siemens Healthcare Diagnostics Inc.
10318905
In Commercial Distribution

  • 00630414473413 ()
T03-4418-54

  • Full blood count IVD, control
ADVIA®120/2120/2120i 3 in 1 TESTpoint™ Low Control
Siemens Healthcare Diagnostics Inc.
10330063
In Commercial Distribution

  • 00630414473406 ()
T03-4417-54

  • Full blood count IVD, control
ADVIA®120/2120/2120i 3-in-1 TESTpoint™ Norm Control
Siemens Healthcare Diagnostics Inc.
10316217
In Commercial Distribution

  • 00630414473390 ()
T03-4416-54

  • Full blood count IVD, control
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