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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® Systems, ACS:180® Systems cPSA 1,2,3 QC - 00630414451732

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

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 Ascorbic Acid Diluent DIL - 00630414451077

Ascorbic Acid - CENTAUR - CAL - 4x30mL
Siemens Healthcare Diagnostics Inc.
10316877
In Commercial Distribution

  • 00630414451077 ()
124975

  • Folate (vitamin B9) IVD, reagent

ADVIA Centaur® FOL DTT/Releasing Agent - 00630414451060

Folate DTT/REL AGT - CENTAUR - CONS - 600 Best.
Siemens Healthcare Diagnostics Inc.
10310382
In Commercial Distribution

  • 00630414451060 ()
124974

  • Dithiothriotol (DTT) reagent IVD

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® 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

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

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® 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

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

BC von Willebrand Reagent - 00630414320366

Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination
Siemens Healthcare Diagnostics Products GmbH
10874080
In Commercial Distribution

  • 00842768018800 ()
  • 00630414320366 ()
10874080

  • von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent

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
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