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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® 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® 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® 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

RAPIDChem® 700 RAPIDPoint® 350 K+ Sensor - 00630414452289

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

Sensor Module Cl- - 00630414452135

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, RAPIDPoint® 340 Trouble shooting kit - 00630414452074

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 Lithium Sensor - 00630414451862

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 RAPIDPoint® 350 Sodium Sensor - 00630414451848

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 - 00630414451824

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 - 00630414451817

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)

ADVIA Centaur® FOL DIL - 00630414451787

Folate BA Dil.RP (2PK) - CENTAUR - CAL - 2x10mL
Siemens Healthcare Diagnostics Inc.
10310389
In Commercial Distribution

  • 00630414451787 ()
  • 00630414003344 ()
125500

  • Buffered sample diluent IVD

ADVIA Centaur® cPSA PRE - 00630414451558

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

ADVIA Centaur® PW 1 - 00630414451220

Probe Wash - CENTAUR - CONS - 1x250 Best.
Siemens Healthcare Diagnostics Inc.
10310358
In Commercial Distribution

  • 00630414451220 ()
123738

  • Buffered wash solution IVD

ADVIA Centaur® Systems. ACS:180® Systems Calibrator Y - 00630414451114

Calibrator Y - 2 pack (cPSA Cal)
Siemens Healthcare Diagnostics Inc.
10310383
In Commercial Distribution

  • 00630414451114 ()
125014

  • Complexed prostate specific antigen (cPSA) IVD, calibrator

ADVIA Centaur® FOL - 00630414450940

Folic Acid - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10325366
In Commercial Distribution

  • 00630414450940 ()
124838

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

ADVIA Centaur® Systems, ACS 180® Systems cPSA MCM - 00630414450872

Complexed Prostate-specific Antigen (cPSA) Master Curve Material Kit
Siemens Healthcare Diagnostics Inc.
10310380
In Commercial Distribution

  • 00630414450872 ()
124828

  • Complexed prostate specific antigen (cPSA) IVD, control

ADVIA Centaur® CA 19-9 MCM - 00630414447926

CA19-9 master material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10325894
In Commercial Distribution

  • 00630414447926 ()
123518

  • Cancer antigen 19-9 (CA19-9) IVD, control

Clinitek Atlas® 10 Reagent PAK for Urine Chemistry - 00630414373003

Clinitek Atlas® 10 Reagent PAK for Urine Chemistry for use with the Clinitek Atlas® Urine Chemistry Analyzer
Siemens Healthcare Diagnostics Inc.
10311120
In Commercial Distribution

  • 00630414373003 ()
5017

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Atellica Connect Test System - 00630414317496

No Description
Siemens Healthcare Diagnostics Inc.
11697146
In Commercial Distribution

  • 00630414317496 ()
11697146

  • Medical equipment clinical data interfacing software

Atellica Connect SE - 00630414317489

No Description
Siemens Healthcare Diagnostics Inc.
11697145
In Commercial Distribution

  • 00630414317489 ()
11697145

  • Medical equipment clinical data interfacing software

Atellica Connect - 00630414317472

No Description
Siemens Healthcare Diagnostics Inc.
11697144
In Commercial Distribution

  • 00630414317472 ()
11697144

  • Medical equipment clinical data interfacing software

ATELLICA HA1C_E HIGH VOLUME CONVERSION KIT - 00630414306179

HA1C_E HIGH VOLUME CONVERSION KIT ATELLICA CH
Siemens Healthcare Diagnostics Inc.
11470732
In Commercial Distribution

  • 00630414306179 ()
11470732

  • Instrument/analyser specimen/reagent container carrier IVD

Atellica Ancillary ReadyPack Seals - 00630414306032

Atellica IM Ancillary Seal Kit
Siemens Healthcare Diagnostics Inc.
11208742
In Commercial Distribution

  • 00630414306032 ()
11208742

  • Assay container liner IVD

Atellica CI 1900 Dilution Cuvette - 00630414304526

Atellica CI 1900 Dilution Cuvette
Siemens Healthcare Diagnostics Inc.
11099501
In Commercial Distribution

  • 00630414304526 ()
11099501

  • Laboratory analyser cuvette IVD, reusable

Atellica CI 1900 Reaction Cuvette - 00630414304519

Atellica CI 1900 Reaction Cuvette
Siemens Healthcare Diagnostics Inc.
11099500
In Commercial Distribution

  • 00630414304519 ()
11099500

  • Laboratory analyser cuvette IVD, reusable

ATELLICA LID KEYING FEATURE KIT - 00630414304328

ATELLICA CH LID KEYING FEATURE KIT
Siemens Healthcare Diagnostics Inc.
11597266
In Commercial Distribution

  • 00630414304328 ()
11597266

  • Instrument/analyser test tube rack cover IVD

ATELLICA HA1C_E HIGH VOLUME LABEL KIT - 00630414304311

HA1C_E HIGH VOLUME LABEL KIT ATELLICA CH (50 LABELS)
Siemens Healthcare Diagnostics Inc.
11597090
In Commercial Distribution

  • 00630414304311 ()
11597090

  • Printer label IVD

ATELLICA HA1C_E HIGH VOLUME BOTTLE KIT - 00630414304304

HA1C_E HIGH VOLUME BOTTLE KIT ATELLICA CH (5 BOTTLES)
Siemens Healthcare Diagnostics Inc.
11597087
In Commercial Distribution

  • 00630414304304 ()
11597087

  • Assay container IVD, reusable

Atellica IM HBeAg - 00630414301310

Hepatitis Be Antigen (HBeAg) - Atellica IM - RGT - 50T
Siemens Healthcare Diagnostics Inc.
11207281
In Commercial Distribution

  • 00630414301310 ()
11207281

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay

Atellica IM FT4 - 00630414293851

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

Atellica IM VitD - 00630414293837

Vitamin D total 25(OH) (VitD) - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206265
In Commercial Distribution

  • 00630414293837 ()
11206265

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

Atellica IM TSH3-UL - 00630414293806

TSH3-UL - Atellica IM - RGT 550T
Siemens Healthcare Diagnostics Inc.
11206304
In Commercial Distribution

  • 00630414293806 ()
11206304

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

Atellica IM ThCG - 00630414293776

HCG Total (ThCG) - Atellica IM - RGT - 450T
Siemens Healthcare Diagnostics Inc.
11206261
In Commercial Distribution

  • 00630414294254 ()
  • 00630414293776 ()
11206261

  • Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay

Atellica IM T3 - 00630414293769

T3 Total (T3) - Atellica IM - RGT 600T
Siemens Healthcare Diagnostics Inc.
11206260
In Commercial Distribution

  • 00630414294247 ()
  • 00630414293769 ()
11206260

  • Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay
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