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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Herpes-2 IgG (HSV2) ADVIA Centaur - RGT – 100T
Siemens Healthcare Diagnostics Inc.
10720849
In Commercial Distribution

  • 00630414016726 ()
10720849

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
for in vitro diagnostic use for multi-level quality control of RAPIDPoint® 400 system only.
Siemens Healthcare Diagnostics Inc.
11046781
In Commercial Distribution

  • 00630414016627 ()
11046781

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Procalcitonin (PCT) Atellica IM - Master Curve Material 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10998265
In Commercial Distribution

  • 00630414014197 ()
10998265

  • Procalcitonin (PCT) IVD, control
Dimension® EXL™ with LM Integrated Chemistry System with Reagent Management System (RMS) and Sample Transfer Module (STM)
Siemens Healthcare Diagnostics Inc.
10718149
In Commercial Distribution

  • 00630414014135 ()
759020.911

  • Multiple clinical chemistry analyser IVD, laboratory
Dimension® EXL™ with LM integrated chemistry system with Reagent Management System (RMS)
Siemens Healthcare Diagnostics Inc.
10475506
In Commercial Distribution

  • 00630414014128 ()
778020.911

  • Multiple clinical chemistry analyser IVD, laboratory
HBc IgM (aHBcM) Assay Kit - 100T
Siemens Healthcare Diagnostics Inc.
10308978
In Commercial Distribution

  • 00630414470498 ()
504619

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Digoxin - ADVIA Chem. - RGT - 4x200 tests
Siemens Healthcare Diagnostics Inc.
10327549
In Commercial Distribution

  • 00630414470375 ()
B01-4769-01

  • Digoxin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
HDL/LDL Cholesterol - ADVIA Chem. - CAL - 3x1mL
Siemens Healthcare Diagnostics Inc.
10311918
In Commercial Distribution

  • 00630414470313 ()
  • 00630414003443 ()
B03-4763-01

  • Multiple lipid analyte IVD, calibrator
HER-2/NEU Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10324496
In Commercial Distribution

  • 00630414469850 ()
131217

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control
TBD
Siemens Healthcare Diagnostics Inc.
10340209
In Commercial Distribution

  • 00630414469454 ()
131096

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
RAPIDPoint® 400 Measurement Cartridge (400 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Hct. For in vitro diagnostic use with RAPIDPoint ® 400 systems.
Siemens Healthcare Diagnostics Inc.
10329756
In Commercial Distribution

  • 00630414469225 ()
130517

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Homocysteine Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10310377
In Commercial Distribution

  • 00630414468235 ()
124583

  • Homocysteine IVD, control
Homocysteine Dil.RP (2PK) - CENTAUR - CAL - 2x10mL
Siemens Healthcare Diagnostics Inc.
10318677
In Commercial Distribution

  • 00630414468211 ()
  • 00630414003535 ()
124581

  • Buffered sample diluent IVD
Homocysteine - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10310376
In Commercial Distribution

  • 00630414468198 ()
124579

  • Homocysteine IVD, calibrator
Homocystein - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10310374
In Commercial Distribution

  • 00630414468174 ()
124577

  • Homocysteine IVD, kit, chemiluminescent immunoassay
HIV RNA 3.0 Assay (bDNA) US IVD (Box 2)
Siemens Healthcare Diagnostics Inc.
10335367
Not in Commercial Distribution

  • 00630414457611 ()
127418B

  • HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)
Anti-TPO Dil.Ancill.RP (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10310391
In Commercial Distribution

  • 00630414457352 ()
  • 00630414003351 ()
125733

  • Buffered sample diluent IVD
Progesterone - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10315522
In Commercial Distribution

  • 00630414454641 ()
125362

  • Progesterone IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® TSTO (5-pack)
Siemens Healthcare Diagnostics Inc.
10339352
Not in Commercial Distribution

  • 00630414454535 ()
  • 00630414010571 ()
126346

  • Total testosterone IVD, kit, chemiluminescent immunoassay
Progesterone (Ref) - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10333111
In Commercial Distribution

  • 00630414454528 ()
  • 00630414010687 ()
126345

  • Progesterone IVD, kit, chemiluminescent immunoassay
RAPIDChem® 700 RAPIDPoint® 340/350 Red Test Dye Solution
Siemens Healthcare Diagnostics Inc.
10318630
In Commercial Distribution

  • 00630414452319 ()
3279837

  • Multiple blood gas analyte IVD, calibrator
RAPIDChem® 700 RAPIDPoint® 350 K+ Sensor, for in vitro diagnostics use with Rapidchem® 700, Rapidpoint 350 systems.
Siemens Healthcare Diagnostics Inc.
10309082
In Commercial Distribution

  • 00630414452289 ()
4955798

  • Potassium (K+) electrode IVD
Valve module an in vitro diagnostics device to be used on the RAPIDChem® 744/754 analyzer
Siemens Healthcare Diagnostics Inc.
10309056
In Commercial Distribution

  • 00630414452142 ()
3372381

  • Blood gas/haemoximetry analyser IVD, point-of-care
Cl- Sensor module an in vitro diagnostics device to be used on the RAPIDChem® 744 analyzer
Siemens Healthcare Diagnostics Inc.
10309086
In Commercial Distribution

  • 00630414452135 ()
5453710

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
RAPIDChem® 700 Urine Diluent for in vitro use with Rapidchem® 700 systems. Contains: buffers & presevatives
Siemens Healthcare Diagnostics Inc.
10308995
In Commercial Distribution

  • 00630414452104 ()
938058

  • Buffered sample diluent IVD
RAPIDChem® 744 Daily Cleaner Kit, for in vitro diagnostics use with Rapidchem® 744 systems.
Siemens Healthcare Diagnostics Inc.
10309011
In Commercial Distribution

  • 00630414452098 ()
1331777

  • Wash/cleaning solution IVD, automated/semi-automated system
Trouble shooting kit for use with RAPIDChem® 700, RAPIDPoint® 340 systems.
Siemens Healthcare Diagnostics Inc.
10317312
In Commercial Distribution

  • 00630414452074 ()
2577729

  • Blood gas/haemoximetry analyser IVD, point-of-care
RAPIDChem® 700 RAPIDPoint® 340/350 Reference Sensor for in vitro diagnostics use with Rapidchem® 700, Rapidpoint ® 340/350 systems.
Siemens Healthcare Diagnostics Inc.
10309034
In Commercial Distribution

  • 00630414451893 ()
2283180

  • Reference electrode IVD
RAPIDChem® 700 Lithium Sensor for in vitro diagnostics use with the Rapidchem ® 700 systems
Siemens Healthcare Diagnostics Inc.
10308981
In Commercial Distribution

  • 00630414451862 ()
583772

  • Lithium electrode IVD
RAPIDChem® 700 Chloride Sensor for in vitro diagnostics use with the Rapidchem ® 700 systems
Siemens Healthcare Diagnostics Inc.
10308989
In Commercial Distribution

  • 00630414451855 ()
661439

  • Chloride (Cl-) electrode IVD
RAPIDChem® 700 RAPIDPoint® 350 Na+ Sensor, for in vitro diagnostics use with Rapidchem® 700, Rapidpoint® 350 systems.
Siemens Healthcare Diagnostics Inc.
10309075
In Commercial Distribution

  • 00630414451848 ()
4473866

  • Sodium (Na+) electrode IVD
RAPIDChem® 754 Na+ K+ Li+ Reagent Module, for in vitro diagnostics use with the Rapidchem® 754 systems.
Siemens Healthcare Diagnostics Inc.
10309093
In Commercial Distribution

  • 00630414451824 ()
5840552

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
RAPIDChem® 744 Na+K+Cl- Reagent Module for in vitro diagnostics use with the Rapidchem® 744 system.
Siemens Healthcare Diagnostics Inc.
10309048
In Commercial Distribution

  • 00630414451817 ()
2970609

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
Folate BA Dil.RP (2PK) - CENTAUR - CAL - 2x10mL
Siemens Healthcare Diagnostics Inc.
10310389
In Commercial Distribution

  • 00630414451787 ()
  • 00630414003344 ()
125500

  • Buffered sample diluent IVD
Complexed Prostate-specific Antigen (cPSA) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10310387
In Commercial Distribution

  • 00630414451732 ()
125425

  • Complexed prostate specific antigen (cPSA) IVD, control
Complexed Prostate-specific Antigen (cPSA) Pre-Treatment Reagent 1-pack
Siemens Healthcare Diagnostics Inc.
10310384
In Commercial Distribution

  • 00630414451558 ()
125308

  • Complexed prostate specific antigen (cPSA) IVD, reagent
Probe Wash - CENTAUR - CONS - 1x250 Best.
Siemens Healthcare Diagnostics Inc.
10310358
In Commercial Distribution

  • 00630414451220 ()
123738

  • Buffered wash solution IVD
Ascorbic Acid - CENTAUR - CAL - 4x30mL
Siemens Healthcare Diagnostics Inc.
10316877
In Commercial Distribution

  • 00630414451077 ()
124975

  • Folate (vitamin B9) IVD, reagent
HBC Total Ab (HBcT) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
11207276
In Commercial Distribution

  • 00630414301303 ()
11207276

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
HAV Total Ab (aHAVT) Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11207271
In Commercial Distribution

  • 00630414301297 ()
11207271

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
CHIV - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11207266
In Commercial Distribution

  • 00630414301280 ()
11207266

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
Anti-HBs2 (aHBs2) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
11207255
In Commercial Distribution

  • 00630414301273 ()
11207255

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
Free T4 (FT4) - Atellica IM - RGT 1250T
Siemens Healthcare Diagnostics Inc.
11206313
In Commercial Distribution

  • 00630414294292 ()
  • 00630414293851 ()
11206313

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
Insulin (IRI) - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
11206267
In Commercial Distribution

  • 00630414293691 ()
11206267

  • Insulin IVD, kit, chemiluminescent immunoassay
Free T3 (FT3) - Atellica IM - RGT 300T
Siemens Healthcare Diagnostics Inc.
11206254
In Commercial Distribution

  • 00630414294186 ()
  • 00630414293677 ()
11206254

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
Follicle Stimulating Hormone (FSH) - Atellica IM - RGT 950T
Siemens Healthcare Diagnostics Inc.
11206253
In Commercial Distribution

  • 00630414294179 ()
  • 00630414293660 ()
11206253

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
Folic Acid (Fol) - Atellica IM - RGT 700T
Siemens Healthcare Diagnostics Inc.
11206252
In Commercial Distribution

  • 00630414293653 ()
11206252

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
Ferritin (Fer) Atellica IM - RGT 450T
Siemens Healthcare Diagnostics Inc.
11206251
In Commercial Distribution

  • 00630414294162 ()
  • 00630414293646 ()
11206251

  • Ferritin IVD, kit, chemiluminescent immunoassay
Estradiol (eE2) - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206250
In Commercial Distribution

  • 00630414293639 ()
11206250

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
DHEAS - Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
11206197
In Commercial Distribution

  • 00630414293622 ()
11206197

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
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