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

Show Filters

Haptoglobin - ADVIA Chem. - RGT - 540 tests
Siemens Healthcare Diagnostics Inc.
10323850
Not in Commercial Distribution

  • 00630414491356 ()
6149314

  • Haptoglobin IVD, kit, nephelometry/turbidimetry
RAPIDChem® 754, RAPIDPoint® 340/350 Daily Cleaner Kit, for in vitro diagonstic use with Rapidchem® 754, Rapidpoint® 340/350 systems
Siemens Healthcare Diagnostics Inc.
10309089
In Commercial Distribution

  • 00630414484587 ()
5610166

  • Wash/cleaning solution IVD, automated/semi-automated system
Li+ Sensor module, an in vitro diagnostics device to be used on the RAPIDChem® 754 analyzer
Siemens Healthcare Diagnostics Inc.
10318482
In Commercial Distribution

  • 00630414484563 ()
3191840

  • Ion-selective analyser IVD, semi-automated
Urine Total Protein - ADVIA Chem. - CAL - 3x5mL
Siemens Healthcare Diagnostics Inc.
10311930
Not in Commercial Distribution

  • 00630414482460 ()
  • 00630414003467 ()
B03-4847-55

  • Total protein IVD, calibrator
Liquid Specific Protein - ADVIA Chem. - CAL - 6x1mL
Siemens Healthcare Diagnostics Inc.
10311929
In Commercial Distribution

  • 00630414482453 ()
B03-4845-01

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Lipase - ADVIA Chem. - RGT - 4x160 tests
Siemens Healthcare Diagnostics Inc.
10311896
In Commercial Distribution

  • 00630414482446 ()
B01-4840-01

  • Lipase IVD, kit, spectrophotometry
RF - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10311894
In Commercial Distribution

  • 00630414482385 ()
B01-4806-01

  • Rheumatoid factor IVD, kit, nephelometry/turbidimetry
Luer Capillary (pack of 20) an in vitro diagnostics device for use on the RAPIDLab® 1200 series analyzers.
Siemens Healthcare Diagnostics Inc.
10309073
In Commercial Distribution

  • 00630414482361 ()
  • 00630414009179 ()
4142460

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Chloride - ADVIA Chem. - RGT - 1 Piece
Siemens Healthcare Diagnostics Inc.
10309439
In Commercial Distribution

  • 00630414482330 ()
073-0049-01

  • Chloride (Cl-) IVD, kit, ion-selective electrode (ISE)
Potassium - ADVIA Chem. - RGT - 1 Piece
Siemens Healthcare Diagnostics Inc.
10309440
In Commercial Distribution

  • 00630414482323 ()
073-0050-01

  • Potassium (K+) IVD, kit, ion-selective electrode (ISE)
Sodium - ADVIA Chem. - RGT - 1 Piece
Siemens Healthcare Diagnostics Inc.
10309441
In Commercial Distribution

  • 00630414482316 ()
073-0051-01

  • Sodium (Na+) IVD, kit, ion-selective electrode (ISE)
No Description
Siemens Healthcare Diagnostics Inc.
10309442
In Commercial Distribution

  • 00630414482309 ()
073-0052-01

  • Reference electrode IVD
Sample Cups - ADVIA Chem. - CONS - 1000 Pieces
Siemens Healthcare Diagnostics Inc.
10309450
In Commercial Distribution

  • 00630414482279 ()
  • 00630414003054 ()
073-0157-02

  • Assay container IVD, single-use
ADVIA® Chemistry Reagent Bottle 70 mL (Brown)
Siemens Healthcare Diagnostics Inc.
10309449
In Commercial Distribution

  • 00630414482262 ()
073-0152-02

  • Multiple clinical chemistry analyser IVD, laboratory
RAPIDPoint® 400/405/500 Wash/Waste Cartridge, for in vitro diagnostics use with the RAPIDPoint® 400/405/500 series systems.
Siemens Healthcare Diagnostics Inc.
10329097
In Commercial Distribution

  • 00630414482163 ()
  • 00630414009612 ()
129672

  • Wash/cleaning solution IVD, automated/semi-automated system
HAV Total - CENTAUR - CONS - 2x2x7mL
Siemens Healthcare Diagnostics Inc.
10322682
In Commercial Distribution

  • 00630414481883 ()
5500077

  • Hepatitis A virus total antibody IVD, control
HAV Total Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10322676
In Commercial Distribution

  • 00630414481876 ()
5498862

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
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
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
Hematek® Stain Pak Modified Wright's Stain
Siemens Healthcare Diagnostics Inc.
10310965
In Commercial Distribution

  • 00630414473499 ()
4481

  • Biological stain IVD
Hematek® Stain Pak Wright-Giemsa Stain
Siemens Healthcare Diagnostics Inc.
10314755
In Commercial Distribution

  • 00630414473482 ()
4405

  • Biological stain IVD
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
ADVIA®120/2120/2120i PEROX SHEATH
Siemens Healthcare Diagnostics Inc.
10312275
In Commercial Distribution

  • 00630414473383 ()
T01-3633-54

  • Full blood count IVD, reagent
HCV(aHCV) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10309062
In Commercial Distribution

  • 00630414473178 ()
3439141

  • Hepatitis C virus total antibody IVD, control
HCV(aHCV) Assay Kit 200T
Siemens Healthcare Diagnostics Inc.
10309061
In Commercial Distribution

  • 00630414473161 ()
3438099

  • Hepatitis C virus total antibody IVD, kit, chemiluminescent assay
Ancillary Probe Wash 12 pack - CENTAUR - CONS - 2x25mL
Siemens Healthcare Diagnostics Inc.
10309060
In Commercial Distribution

  • 00630414472898 ()
  • 00630414003030 ()
3395373

  • Buffered wash solution IVD
HBsAg (HBs) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10309059
In Commercial Distribution

  • 00630414472881 ()
3394660

  • Hepatitis B virus surface antigen IVD, control
HBsAg Conf (Confirmatory) Assay Kit
Siemens Healthcare Diagnostics Inc.
10309058
In Commercial Distribution

  • 00630414472874 ()
3393818

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay
Small Sample Container (SSC) - Dimension® - 1000 Pieces
Siemens Healthcare Diagnostics Inc.
10445040
In Commercial Distribution

  • 00842768005909 ()
  • 00630414004662 ()
DSC5

  • Assay container IVD, single-use
Sample Cups - Dimension® and Dimension Vista® - 1000 X1.5 mL
Siemens Healthcare Diagnostics Inc.
10445041
In Commercial Distribution

  • 00842768005893 ()
  • 00630414004679 ()
DSC4

  • Assay container IVD, single-use
EMPTY Flex® reagent cartridge, 8 Flex
Siemens Healthcare Diagnostics Inc.
10445039
In Commercial Distribution

  • 00842768005886 ()
  • 00630414004655 ()
DF99

  • Assay container IVD, single-use
Urine Benzodiazepines Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444919
In Commercial Distribution

  • 00842768005879 ()
  • 00630414004051 ()
DF97A

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
Urine Cannabinoids Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444925
In Commercial Distribution

  • 00842768005855 ()
  • 00630414004112 ()
DF95A

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Urine Opiates Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444923
In Commercial Distribution

  • 00842768005831 ()
  • 00630414004099 ()
DF93A

  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
< 1 ... 86 87 88 89 90 ... 145 >