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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Microalbumin - ADVIA Chem. - CAL - 5x2mL
Siemens Healthcare Diagnostics Inc.
10337470
In Commercial Distribution

  • 00630414534077 ()
6487733

  • Microalbumin IVD, calibrator
Quality control for Siemens urine strips read visually and all analyzers other than Clinitek Atlas® and Clinitek Novus® - 25 positive strips
Siemens Healthcare Diagnostics Inc.
10310482
In Commercial Distribution

  • 00630414532844 ()
  • 00630414009230 ()
1360

  • Multiple urine analyte IVD, control
Quality control for Siemens urine strips read visually and all analyzers other than Clinitek Atlas® and Clinitek Novus® - 25 positive and 25 negative strips
Siemens Healthcare Diagnostics Inc.
10310483
In Commercial Distribution

  • 00630414532837 ()
1364

  • Multiple urine analyte IVD, control
DCA HbA1c Test Kit (monitoring only) - INTL.
Siemens Healthcare Diagnostics Inc.
10311134
In Commercial Distribution

  • 00630414532806 ()
5035C

  • Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography
DCA Microablumin Creatinine Test Kit (ACR test).
Siemens Healthcare Diagnostics Inc.
10311480
In Commercial Distribution

  • 00630414532790 ()
6011A

  • Microalbumin IVD, kit, spectrophotometry
Hepatitis B e Antigen (HBeAg) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10338289
In Commercial Distribution

  • 00630414531298 ()
6981117

  • Hepatitis B virus e-antigen immunoglobulin G (IgG) antibody IVD, control
Valproic Acid Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10322232
Not in Commercial Distribution

  • 00630414527369 ()
5261307

  • Valproic acid therapeutic drug monitoring IVD, control
Valproic Acid - CENTAUR - CAL - 6x6x5mL
Siemens Healthcare Diagnostics Inc.
10322227
Not in Commercial Distribution

  • 00630414527352 ()
5260521

  • Valproic acid therapeutic drug monitoring IVD, calibrator
Valproic Acid - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10322222
Not in Commercial Distribution

  • 00630414527345 ()
5259132

  • Valproic acid therapeutic drug monitoring IVD, calibrator
Valproic Acid - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10322218
Not in Commercial Distribution

  • 00630414527338 ()
  • 00630414027647 ()
5258292

  • Valproic acid therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Valproic Acid - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10322215
Not in Commercial Distribution

  • 00630414527321 ()
5256877

  • Valproic acid therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Gentamicin Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10322163
Not in Commercial Distribution

  • 00630414527307 ()
5227559

  • Gentamicin therapeutic drug monitoring IVD, control
Gentamicin - CENTAUR - CAL - 6x6x2mL
Siemens Healthcare Diagnostics Inc.
10322161
Not in Commercial Distribution

  • 00630414527291 ()
5226870

  • Gentamicin therapeutic drug monitoring IVD, calibrator
Gentamicin - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10322159
Not in Commercial Distribution

  • 00630414527284 ()
5226110

  • Gentamicin therapeutic drug monitoring IVD, calibrator
Gentamicin - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10322154
Not in Commercial Distribution

  • 00630414527277 ()
5223979

  • Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Phenobarbital - CENTAUR - CAL - 6x2x2mL
Siemens Healthcare Diagnostics Inc.
10322093
Not in Commercial Distribution

  • 00630414527215 ()
5191007

  • Phenobarbital therapeutic drug monitoring IVD, calibrator
Phenobarbital - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10322092
Not in Commercial Distribution

  • 00630414527208 ()
5190965

  • Phenobarbital therapeutic drug monitoring IVD, calibrator
Phenobarbital - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10322090
Not in Commercial Distribution

  • 00630414527192 ()
5190841

  • Phenobarbital therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Carbamazepine Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10322042
Not in Commercial Distribution

  • 00630414527178 ()
5166886

  • Carbamazepine therapeutic drug monitoring IVD, control
Carbamazepin (6PK) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10322040
Not in Commercial Distribution

  • 00630414527161 ()
5165553

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator
Carbamazepine ADVIA CENTAUR2PK - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10322039
Not in Commercial Distribution

  • 00630414527154 ()
5165359

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator
Carbamazepine - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10322035
Not in Commercial Distribution

  • 00630414527147 ()
  • 00630414027630 ()
5163003

  • Carbamazepine therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Carbamazepine - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10322033
Not in Commercial Distribution

  • 00630414527130 ()
5162724

  • Carbamazepine therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Benzodiazepines - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10335939
Not in Commercial Distribution

  • 00630414526928 ()
5042192

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
Barbiturates - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10335934
Not in Commercial Distribution

  • 00630414526911 ()
5040084

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
TBD
Siemens Healthcare Diagnostics Inc.
10335933
Not in Commercial Distribution

  • 00630414526904 ()
5038055

  • 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)
CRP (High Sensitivity) Level 6 - ADVIA Chem. - CAL - 6x1mL
Siemens Healthcare Diagnostics Inc.
10335897
In Commercial Distribution

  • 00630414526843 ()
5006455

  • C-reactive protein (CRP) IVD, calibrator
Triglyceride - ADVIA Chem. - RGT - 4x358/4x362 tests
Siemens Healthcare Diagnostics Inc.
10335892
In Commercial Distribution

  • 00630414526829 ()
  • 00630414003733 ()
5001860

  • Triglyceride IVD, kit, spectrophotometry
Glucose - ADVIA Chem. - RGT - 6x660/6x470 tests
Siemens Healthcare Diagnostics Inc.
10335891
In Commercial Distribution

  • 00630414526812 ()
5001429

  • Glucose IVD, kit, spectrophotometry
Protein - ADVIA Chem. - RGT - 4x194 tests
Siemens Healthcare Diagnostics Inc.
10335885
Not in Commercial Distribution

  • 00630414526782 ()
  • 00630414003726 ()
5000171

  • Total protein IVD, kit, enzyme spectrophotometry
ISE Buffer Large - ADVIA Chem. - CONS - 3 Liter
Siemens Healthcare Diagnostics Inc.
10321715
In Commercial Distribution

  • 00630414526768 ()
4997873

  • pH-adjusted buffer solution IVD
Cholesterol - ADVIA Chem. - Conc. RGT - 4x2100/4x1340 tests
Siemens Healthcare Diagnostics Inc.
10335874
In Commercial Distribution

  • 00630414526744 ()
  • 00630414003719 ()
4993681

  • Total cholesterol lipid IVD, kit, spectrophotometry
Uric Acid - ADVIA Chem. - RGT - 6x1250 tests
Siemens Healthcare Diagnostics Inc.
10335873
In Commercial Distribution

  • 00630414526737 ()
4993452

  • Uric acid IVD, kit, spectrophotometry
Glucose - ADVIA Chem. - Conc. RGT - 8480/5200 tests
Siemens Healthcare Diagnostics Inc.
10335872
In Commercial Distribution

  • 00630414526720 ()
  • 00630414003702 ()
4993223

  • Glucose IVD, kit, spectrophotometry
Magnesium - ADVIA Chem. - RGT - 6x1270 tests
Siemens Healthcare Diagnostics Inc.
10335871
In Commercial Distribution

  • 00630414526713 ()
4992960

  • Magnesium (Mg2+) IVD, kit, spectrophotometry
Albumin - ADVIA Chem. - Conc. RGT - 4x1700/- tests
Siemens Healthcare Diagnostics Inc.
10335870
In Commercial Distribution

  • 00630414526706 ()
  • 00630414003696 ()
4992820

  • Albumin IVD, kit, nephelometry/turbidimetry
Creatinine enzymatic - ADVIA Chem. - RGT - 4x350 tests
Siemens Healthcare Diagnostics Inc.
10335869
Not in Commercial Distribution

  • 00630414526690 ()
4992596

  • Creatinine IVD, kit, spectrophotometry
Multidil 12 CSA - CENTAUR - CONS - 1x20mL
Siemens Healthcare Diagnostics Inc.
10335692
In Commercial Distribution

  • 00630414525549 ()
4786546

  • Buffered sample diluent IVD
Probe Wash 4 - CENTAUR - CONS - 1x25mL
Siemens Healthcare Diagnostics Inc.
10321290
In Commercial Distribution

  • 00630414525464 ()
4750940

  • Buffered wash solution IVD
Cortisol - Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10309080
In Commercial Distribution

  • 00630414524740 ()
4639454

  • Total cortisol IVD, control
(ECOR) - CENTAUR 180 - CAL E
Siemens Healthcare Diagnostics Inc.
10335532
In Commercial Distribution

  • 00630414524733 ()
4636889

  • Multiple steroid hormone IVD, calibrator
Cortisol (6PK) - CENTAUR - CAL - 6x2x2mL
Siemens Healthcare Diagnostics Inc.
10321075
In Commercial Distribution

  • 00630414524726 ()
4634762

  • Multiple steroid hormone IVD, calibrator
Cortisol (2PK) - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10309079
In Commercial Distribution

  • 00630414524719 ()
4634452

  • Multiple steroid hormone IVD, calibrator
Cortisol - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10321026
In Commercial Distribution

  • 00630414524610 ()
  • 00630414011158 ()
4610138

  • Total cortisol IVD, kit, chemiluminescent immunoassay
Cortisol - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10309078
In Commercial Distribution

  • 00630414524603 ()
4610049

  • Total cortisol IVD, kit, chemiluminescent immunoassay
Cyclosporine - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10335454
In Commercial Distribution

  • 00630414524481 ()
4567682

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
CSA Pretreatment - CENTAUR - CONS - 2x26mL
Siemens Healthcare Diagnostics Inc.
10335453
In Commercial Distribution

  • 00630414524474 ()
  • 00630414003689 ()
4567127

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent
Cyclosporine - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10335448
In Commercial Distribution

  • 00630414524450 ()
4564446

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Wash 1 - CENTAUR - CONS - 2x2500mL
Siemens Healthcare Diagnostics Inc.
10319550
In Commercial Distribution

  • 00630414524139 ()
  • 00630414003559 ()
3773025

  • Buffered wash solution IVD
CSA Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10334651
In Commercial Distribution

  • 00630414523798 ()
3685177

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control
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