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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® XP Analyzer - 00630414573564

ADVIA® CENTAUR® XP Instrument
Siemens Healthcare Diagnostics Inc.
10364455
In Commercial Distribution

  • 00630414573564 ()
078-A011-03

  • Chemiluminescent immunoassay analyser IVD

ADVIA Centaur® eE2 - 00630414573342

Estradiol - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10490889
In Commercial Distribution

  • 00630414573342 ()
10490889

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

RAPIDPoint ® 340/350 Capillary Tubes 100ul - 00630414566283

Capillary Tube Kit, for use with RapidPoint® 340/350 analyzers; contents: 2 vials (100 each) capillary tubes, 1 bag (500) end caps
Siemens Healthcare Diagnostics Inc.
10375804
In Commercial Distribution

  • 00630414566283 ()
10375804

  • Capillary blood collection tube IVD, lithium heparin

ADVIA Centaur® TSH3-UL MCM - 00630414565668

TSH3-UL Master Curve Material Set - CENTAUR - CAL
Siemens Healthcare Diagnostics Inc.
10285735
In Commercial Distribution

  • 00630414565668 ()
4782400

  • Thyroid stimulating hormone (TSH) IVD, control

DCA 2000® Microalbumin Creatinine control kit - 00630414535722

The DCA Microalbumin Creatinine Control Kit contains both Low Controls and High Controls. Each control is a buffered aqueous solution containing known amounts of human albumin and creatinine. The resulting mixture is then lyophilized to ensure stability. The DCA Microalbumin Creatinine Control Kit has been designed for use with the DCA Microalbumin Creatinine Reagent Kit.
Siemens Healthcare Diagnostics Inc.
10325406
In Commercial Distribution

  • 00630414535722 ()
6012A

  • Microalbumin IVD, control

ADVIA Centaur® DHEA-S MCM - 00630414535340

DHEA-S Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10282214
In Commercial Distribution

  • 00630414535340 ()
6489752

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, control

ADVIA Centaur® DHEAS - 00630414535333

DHEA-S - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10282227
In Commercial Distribution

  • 00630414535333 ()
6489701

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

ADVIA® 1800 Analyzer - 00630414534794

ADVIA® 1800 Instrument
Siemens Healthcare Diagnostics Inc.
10315183
In Commercial Distribution

  • 00630414534794 ()
073-A021-01

  • Multiple clinical chemistry analyser IVD, laboratory

Chek-Stix® Control+ strips - 00630414532844

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

Chek-Stix® Combo Pak Control+ Control- Strips - 00630414532837

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
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