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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® IRI DIL - 00630414466187

Insulin Dil.RP (2PK) - CENTAUR - CAL - 2x10mL
Siemens Healthcare Diagnostics Inc.
10310462
In Commercial Distribution

  • 00630414466187 ()
  • 00630414003375 ()
129883

  • Buffered sample diluent IVD

RAPIDSystems™ AutomaticQC Cartridge - 00630414465883

For in vitro diagnostic use for multi-level quality control of RAPIDPoint 400/500 series and RAPIDLab 1200 series systems.
Siemens Healthcare Diagnostics Inc.
10310323
In Commercial Distribution

  • 00630414465883 ()
120241

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

ADVIA® Chemistry CHE Cholinesterase Reagents - 00630414465401

PCHE - ADVIA Chem. - RGT - 4x133 tests
Siemens Healthcare Diagnostics Inc.
10329639
In Commercial Distribution

  • 00630414465401 ()
B01-4605-01

  • Acetylcholinesterase IVD, kit, spectrophotometry

ADVIA® Chemistry TP Total Protein II Reagents - 00630414465227

Total Protein - ADVIA Chem. - RGT - 4x850/4x700 tests
Siemens Healthcare Diagnostics Inc.
10311878
In Commercial Distribution

  • 00630414465227 ()
B01-4601-01

  • Total protein IVD, kit, spectrophotometry

ADVIA Centaur® CpS - 00630414464053

C-Peptide - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10310448
In Commercial Distribution

  • 00630414464053 ()
129026

  • C-peptide IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® CpS MCM - 00630414464022

C-Peptide S Master Curve Material Kit - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10310446
In Commercial Distribution

  • 00630414464022 ()
129023

  • C-peptide IVD, control

ADVIA Centaur® Systems, ACS:180® Systems CpS Calibrator - 00630414464008

C-Peptide - CENTAUR - CAL - 2x2x1mL
Siemens Healthcare Diagnostics Inc.
10310445
In Commercial Distribution

  • 00630414464008 ()
129021

  • C-peptide IVD, calibrator

ADVIA Centaur® Systems, ACS:180® Systems CA 15-3® Calibrator - 00630414461359

CA 15-3 - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10329796
In Commercial Distribution

  • 00630414461359 ()
128538

  • Cancer antigen 15-3 (CA15-3) IVD, calibrator

ADVIA Centaur® Systems CA 125II Calibrator - 00630414461335

CA125 - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10310444
In Commercial Distribution

  • 00630414461335 ()
128536

  • Cancer antigen 125 (CA125) IVD, calibrator

ADVIA Centaur® CA 15-3® - 00630414461328

CA 15-3 - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10312831
In Commercial Distribution

  • 00630414461328 ()
  • 00630414003481 ()
128535

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® CA 15-3® - 00630414461311

CA 15-3 - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10327620
In Commercial Distribution

  • 00630414461311 ()
128534

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® CA 125 II - 00630414461304

CA 125 - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10315696
In Commercial Distribution

  • 00630414461304 ()
  • 00630414003504 ()
128533

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

ADVIA Centaur® CA 125II - 00630414461298

CA 125 - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10310443
In Commercial Distribution

  • 00630414461298 ()
128532

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

ADVIA Centaur® CA 15-3® MCM - 00630414461281

CA15-3 master curve material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10330854
In Commercial Distribution

  • 00630414461281 ()
128531

  • Cancer antigen 15-3 (CA15-3) IVD, control

ADVIA Centaur® CA 125II MCM - 00630414461274

CA 125 II Master Curve Material Kit - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10310442
In Commercial Distribution

  • 00630414461274 ()
128530

  • Cancer antigen 125 (CA125) IVD, control

ADVIA Centaur® IRI - 00630414461021

Insulin - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10310439
In Commercial Distribution

  • 00630414461021 ()
128434

  • Insulin IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® Systems, ACS:180® Systems CAL IRI Calibrator - 00630414461014

Insulin - CENTAUR - CAL - 2x2x1mL
Siemens Healthcare Diagnostics Inc.
10310438
In Commercial Distribution

  • 00630414461014 ()
128433

  • Insulin IVD, calibrator

ADVIA Centaur® IRI MCM - 00630414461007

Insulin Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10310437
In Commercial Distribution

  • 00630414461007 ()
128432

  • Insulin IVD, control

ADVIA Centaur® THEO 2 - 00630414460963

Theophyline - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10328931
Not in Commercial Distribution

  • 00630414460963 ()
  • 00630414027661 ()
128380

  • Theophylline therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® THEO 2 - 00630414460956

Theophyline - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10310434
Not in Commercial Distribution

  • 00630414460956 ()
128379

  • Theophylline therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® Systems Calibrator 27 - 00630414460918

Theophylline - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10310432
Not in Commercial Distribution

  • 00630414460918 ()
128304

  • Theophylline therapeutic drug monitoring IVD, calibrator

ADVIA Centaur® aTG DIL - 00630414460833

TG Ab Dil.Ancill.RP (2PK) - CENTAUR - CONS - 2x5mL
Siemens Healthcare Diagnostics Inc.
10310430
In Commercial Distribution

  • 00630414460833 ()
  • 00630414003368 ()
128280

  • Buffered sample diluent IVD

VERSANT® HIV-1 RNA 3.0 Assay bDNA - 00630414457611

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)

VERSANT® HIV-1 RNA 3.0 Assay bDNA - 00630414457604

HIV RNA 3.0 Assay (bDNA) US IVD (Box 1)
Siemens Healthcare Diagnostics Inc.
10335480
Not in Commercial Distribution

  • 00630414457604 ()
127418A

  • HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)

ADVIA Centaur® aTPO Diluent - 00630414457352

Anti-TPO Dil.Ancill.RP (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10310391
In Commercial Distribution

  • 00630414457352 ()
  • 00630414003351 ()
125733

  • Buffered sample diluent IVD

ADVIA Centaur® TSTO +E - 00630414454658

Testosterone - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10322623
Not in Commercial Distribution

  • 00630414454658 ()
  • 00630414010519 ()
125363

  • Total testosterone IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® PRGE +E - 00630414454641

Progesterone - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10315522
In Commercial Distribution

  • 00630414454641 ()
125362

  • Progesterone IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® FOL - 00630414454597

Folic Acid (Ref) - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10331250
In Commercial Distribution

  • 00630414454597 ()
126638

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

ADVIA Centaur® TSTO - 00630414454535

ADVIA Centaur® TSTO (5-pack)
Siemens Healthcare Diagnostics Inc.
10339352
Not in Commercial Distribution

  • 00630414454535 ()
  • 00630414010571 ()
126346

  • Total testosterone IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® Progesterone (PRGE) - 00630414454528

Progesterone (Ref) - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10333111
In Commercial Distribution

  • 00630414454528 ()
  • 00630414010687 ()
126345

  • Progesterone IVD, kit, chemiluminescent immunoassay
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