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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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ADVIA Centaur® cPSA - 00630414450896

Complexed Prostate-specific Antigen (cPSA) Assay Kit 100T
Siemens Healthcare Diagnostics Inc.
10310381
In Commercial Distribution

  • 00630414450896 ()
124830

  • Complexed prostate specific antigen (cPSA) IVD, kit, chemiluminescent immunoassay

RAPIDPoint® 400/405/500 Wash/Waste Cartridge - 00630414444581

RAPIDPoint® 400/405/500 Wash/Waste Cartridge is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 400/405/500 analyzers.
Siemens Healthcare Diagnostics Inc.
10310310
In Commercial Distribution

  • 00630414444581 ()
  • 00630414009223 ()
118677

  • Wash/cleaning solution IVD, automated/semi-automated system

RAPIDPoint® 400 Measurement Cartridge - 00630414443492

RAPIDPoint® 400 Measurement Cartridge (750 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Hct for in vitro diagnostic use with RAPIDPoint® 400 systems.
Siemens Healthcare Diagnostics Inc.
10341161
In Commercial Distribution

  • 00630414443492 ()
118679

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

RAPIDPoint® 400/405/500 Wash/Waste Cartridge - 00630414443485

RAPIDPoint® 400/405/500 Wash/Waste Cartridge for in vitro diagnostics use with the RAPIDPoint® 400/405/500 series systems.
Siemens Healthcare Diagnostics Inc.
10341179
In Commercial Distribution

  • 00630414443485 ()
118678

  • Wash/cleaning solution IVD, automated/semi-automated system

ADVIA Centaur® VANC - 00630414443096

Vancomycin - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10323243
Not in Commercial Distribution

  • 00630414443096 ()
  • 00630414011165 ()
121197

  • Vancomycin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® VB12 DTT/Releasing Agent - 00630414443010

Vitamin B12 RA Kit - CENTAUR - CONS - 1 Kit
Siemens Healthcare Diagnostics Inc.
10310330
In Commercial Distribution

  • 00630414443010 ()
121093

  • Vitamin B12 IVD, reagent

CLINITEK Atlas® Control- Strips. - 00630414374109

Quality control for CLINITEK Atlas® and CLINITEK Novus® analyzers
Siemens Healthcare Diagnostics Inc.
10311135
In Commercial Distribution

  • 00630414374109 ()
  • 00630414009322 ()
5037

  • Multiple urine analyte IVD, control

CLINITEK Atlas® Control+ Strips - 00630414373201

Quality control for CLINITEK Atlas® and CLINITEK Novus® analyzers
Siemens Healthcare Diagnostics Inc.
10311124
In Commercial Distribution

  • 00630414373201 ()
  • 00630414009315 ()
5019

  • Multiple urine analyte IVD, control

Clinitek Atlas® Calibration Kit - 00630414373027

Clinitek Atlas® Calibration Kit. For use with CLINITEK ATLAS® Automated Urine Chemistry System.
Siemens Healthcare Diagnostics Inc.
10311123
In Commercial Distribution

  • 00630414373027 ()
5018A

  • Multiple urine analyte IVD, control

Clinitek Atlas® Rinse Additiive - 00630414372464

Rinse additive, an in vitro diagnostics device for use on the CLINITEK Atlas® automated urine chemistry system
Siemens Healthcare Diagnostics Inc.
10311113
In Commercial Distribution

  • 00630414372464 ()
  • 00630414009308 ()
5007A

  • Buffered wash solution IVD

Clinitek Atlas® Calibrator #4 - 00630414372181

Clinitek Atlas® Calibrator #4 In vitro diagnostic medical device
Siemens Healthcare Diagnostics Inc.
10311106
In Commercial Distribution

  • 00630414372181 ()
5006

  • Multiple urine analyte IVD, control

Atellica IM aHCV 200T - 00630414301341

Atellica IM aHCV 200T Kit
Siemens Healthcare Diagnostics Inc.
11207260
In Commercial Distribution

  • 00630414301341 ()
11207260

  • Hepatitis C virus total antibody IVD, kit, chemiluminescent assay

Atellica IM VitD QC - 00630414301334

Vitamin D total 25(OH) (VitD) QC Kit Atellica IM - CLT 2 x 3 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11207292
In Commercial Distribution

  • 00630414301334 ()
11207292

  • Multiple form 25-hydroxy Vitamin D IVD, control

Atellica IM HBsII - 00630414301327

HBsAgII (HBsII) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
11207286
In Commercial Distribution

  • 00630414301327 ()
11207286

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Atellica IM HBcT - 00630414301303

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

Atellica IM aHAVT - 00630414301297

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

Atellica IM CHIV - 00630414301280

CHIV - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11207266
In Commercial Distribution

  • 00630414301280 ()
11207266

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

Atellica IM aHBs2 - 00630414301273

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

Atellica IM aHBcM - 00630414301266

HBc IgM (aHBcM) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11207249
In Commercial Distribution

  • 00630414301266 ()
11207249

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Atellica IM aHAVM - 00630414301259

HAV IgM Ab (aHAVM) - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
11207243
In Commercial Distribution

  • 00630414301259 ()
11207243

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Atellica IM TSH3-UL - 00630414293875

TSH3-UL - Atellica IM - RGT 2750T
Siemens Healthcare Diagnostics Inc.
11206262
In Commercial Distribution

  • 00630414293875 ()
11206262

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

Atellica IM SHBG - 00630414293868

Sex Hormone Binding Globulin (SHBG) - Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206312
In Commercial Distribution

  • 00630414294285 ()
  • 00630414293868 ()
11206312

  • Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay

Atellica IM DHEAS - 00630414293844

DHEAS - Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206311
In Commercial Distribution

  • 00630414293844 ()
11206311

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

Atellica IM VB12 - 00630414293820

Vitamin B12 (VB12) - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206264
In Commercial Distribution

  • 00630414294261 ()
  • 00630414293820 ()
11206264

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay

Atellica IM TSTII - 00630414293813

Testoterone II (TSTII) - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206263
In Commercial Distribution

  • 00630414293813 ()
11206263

  • Total testosterone IVD, kit, chemiluminescent immunoassay

Atellica IM TnI-Ultra - 00630414293790

TnI-Ultra - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206219
In Commercial Distribution

  • 00630414293790 ()
11206219

  • Troponin I IVD, kit, chemiluminescent immunoassay

Atellica IM TNIH - 00630414293783

High Sensitivity Troponin I (TnIH) - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206269
In Commercial Distribution

  • 00630414293783 ()
11206269

  • Troponin I IVD, kit, chemiluminescent immunoassay

Atellica IM FSH - 00630414293660

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

Atellica IM Fol - 00630414293653

Folic Acid (Fol) - Atellica IM - RGT 700T
Siemens Healthcare Diagnostics Inc.
11206252
In Commercial Distribution

  • 00630414293653 ()
11206252

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay

Atellica IM Fer - 00630414293646

Ferritin (Fer) Atellica IM - RGT 450T
Siemens Healthcare Diagnostics Inc.
11206251
In Commercial Distribution

  • 00630414294162 ()
  • 00630414293646 ()
11206251

  • Ferritin IVD, kit, chemiluminescent immunoassay

Atellica IM eE2 - 00630414293639

Estradiol (eE2) - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206250
In Commercial Distribution

  • 00630414293639 ()
11206250

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay

Atellica IM DHEAS - 00630414293622

DHEAS - Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
11206197
In Commercial Distribution

  • 00630414293622 ()
11206197

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

Atellica IM CpS - 00630414293615

C-Peptide (CpS) - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
11206249
In Commercial Distribution

  • 00630414293615 ()
11206249

  • C-peptide IVD, kit, chemiluminescent immunoassay

Atellica IM Cor - 00630414293608

Cortisol - Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206248
In Commercial Distribution

  • 00630414294155 ()
  • 00630414293608 ()
11206248

  • Total cortisol IVD, kit, chemiluminescent immunoassay

Atellica IM CKMB - 00630414293592

CKMB - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206247
In Commercial Distribution

  • 00630414294148 ()
  • 00630414293592 ()
11206247

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay

Atellica IM Calibrator E - 00630414293578

Calibrator E - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11206245
In Commercial Distribution

  • 00630414294124 ()
  • 00630414293578 ()
11206245

  • Multiple steroid hormone IVD, calibrator

Atellica IM Calibrator D - 00630414293561

Calibrator D - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11206244
In Commercial Distribution

  • 00630414294117 ()
  • 00630414293561 ()
11206244

  • Multiple tissue-associated protein/tumour marker IVD, calibrator

Atellica IM Calibrator B - 00630414293547

Calibrator B - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11206242
In Commercial Distribution

  • 00630414294094 ()
  • 00630414293547 ()
11206242

  • Multiple human hormone IVD, calibrator

Atellica IM Calibrator 30 - 00630414293523

Calibrator 30 - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11206240
In Commercial Distribution

  • 00630414294070 ()
  • 00630414293523 ()
11206240

  • Multiple steroid hormone IVD, calibrator

Atellica IM CA 19-9 - 00630414293516

CA 19-9 Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206239
In Commercial Distribution

  • 00630414293516 ()
11206239

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

Atellica IM CA 125II - 00630414293493

CA 125II Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206266
In Commercial Distribution

  • 00630414294278 ()
  • 00630414293493 ()
11206266

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

Atellica IM Androstenedione MCM - 00630414285559

Androstenedione (Andro) Atellica IM - Master Curve Material 5x1x1.0mL
Siemens Healthcare Diagnostics Inc.
11200557
In Commercial Distribution

  • 00630414285559 ()
11200557

  • Androstenedione IVD, control

Atellica IM VitD - 00630414234489

Vitamin D total 25(OH) (VitD) - Atellica™ IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
11201773
In Commercial Distribution

  • 00630414234489 ()
11201773

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay

Atellica IM VitD - 00630414234472

Vitamin D total 25(OH) (VitD) - Atellica™ IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11201772
In Commercial Distribution

  • 00630414234472 ()
11201772

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay

Syva Emit II Plus 6-Acetylmorphine Assay - 00630414229591

Syva Emit II Plus 6-Acetylmorphine Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10730975
In Commercial Distribution

  • 00630414229591 ()
9R029UL

  • 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)

Atellica CI Rack Handler - 00630414229560

Atellica CI Rack Handler
Siemens Healthcare Diagnostics Inc.
10947348
In Commercial Distribution

  • 00630414229560 ()
10947348

  • Specimen processing instrument IVD

Atellica CI Analyzer - 00630414229553

Atellica CI Analyzer
Siemens Healthcare Diagnostics Inc.
10947347
In Commercial Distribution

  • 00630414229553 ()
10947347

  • Multiple clinical chemistry analyser IVD, laboratory

ADVIA Centaur AMH Kit - 00630414225692

AMH - Centaur - RGT – 100T
Siemens Healthcare Diagnostics Inc.
10998432
In Commercial Distribution

  • 00630414225692 ()
10998432

  • Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur MH MCM Set - 00630414225685

AMH - Centaur - Master Curve Material Kit 4 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10998430
In Commercial Distribution

  • 00630414225685 ()
10998430

  • Anti-Mullerian hormone (AMH) IVD, control

ADVIA® 120/2120/2120i TESTpoint Retic Low Control - 00630414224428

ADVIA®120/2120/2120i TESTpoint™ Retic Control Low
Siemens Healthcare Diagnostics Inc.
10312293
In Commercial Distribution

  • 00630414224428 ()
T03-3690-54

  • Reticulocyte count IVD, control
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