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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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Multistix PRO® 10LS Reagent Strips - 00630414549255

Siemens Healthcare Diagnostics MULTISTIX PRO® 10LS Reagent Strips for Urinalysis include test pads for protein-high, protein-low, creatinine, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid), pH, and specific gravity.
Siemens Healthcare Diagnostics Inc.
10331147
In Commercial Distribution

  • 00630414549255 ()
  • 00630414009636 ()
A1554C16

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

Uristix® Reagent Strips - 00630414549132

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein and glucose.
Siemens Healthcare Diagnostics Inc.
10339520
In Commercial Distribution

  • 00630414549132 ()
  • 00630414009728 ()
A2184B16

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

Combistix® Reagent Strips - 00630414549125

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, glucose and pH.
Siemens Healthcare Diagnostics Inc.
10337932
In Commercial Distribution

  • 00630414549125 ()
  • 00630414009704 ()
A2183B16

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

Hema-Combistix® Reagent Strips - 00630414549118

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, glucose and pH.
Siemens Healthcare Diagnostics Inc.
10338451
In Commercial Distribution

  • 00630414549118 ()
  • 00630414009711 ()
A2182B16

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

Labstix® Reagent Strips - 00630414549101

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, glucose, ketone (aceto-acetic acietic acid) and pH
Siemens Healthcare Diagnostics Inc.
10337069
In Commercial Distribution

  • 00630414549101 ()
  • 00630414009674 ()
A2181B16

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

Uristix® 4 Reagent Strips - 00630414549057

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, leukocytes, nitrite, glucose.
Siemens Healthcare Diagnostics Inc.
10312569
In Commercial Distribution

  • 00630414549057 ()
  • 00630414009377 ()
A2166B16

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

Multistix® 7 Reagent Strips - 00630414549040

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid) and pH.
Siemens Healthcare Diagnostics Inc.
10326145
In Commercial Distribution

  • 00630414549040 ()
  • 00630414009582 ()
A2165C16

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

Multistix® 8 SG Reagent Strips - 00630414549033

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (aceto-acetic acid), pH and specific gravity.
Siemens Healthcare Diagnostics Inc.
10337913
In Commercial Distribution

  • 00630414549033 ()
  • 00630414009698 ()
A2164C16

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

Multistix® 9 SG Reagent Strips - 00630414549026

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (aceto-acetic acid), pH, specific gravity and bilirubin
Siemens Healthcare Diagnostics Inc.
10337216
In Commercial Distribution

  • 00630414549026 ()
  • 00630414009681 ()
A2163B16

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

Multistix® 9 Reagent Strips - 00630414549019

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid), pH, bilirubin and urobilinogen
Siemens Healthcare Diagnostics Inc.
10329874
In Commercial Distribution

  • 00630414549019 ()
  • 00630414009629 ()
A2162B16

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

Multistix® 10 SG Reagent Strips - 00630414548968

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (aceto-acetic acid), pH, specific gravity, bilirubin and urobilinogen.
Siemens Healthcare Diagnostics Inc.
10336425
In Commercial Distribution

  • 00630414548968 ()
  • 00630414009667 ()
A2161B16

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

CLINITEK® Microalbumin 2 Reagent Strips - 00630414548951

CLINITEK® Microalbumin 2 Reagent Strips are firm plastic strips that contain two reagent pads that test for albumin and creatinine in urine.
Siemens Healthcare Diagnostics Inc.
10317439
In Commercial Distribution

  • 00630414548951 ()
  • 00630414009452 ()
A2083C24

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

VERSANT® kPCR Molecular System SP - 00630414541457

VERSANT® kPCR Molecular System Sample Preparation Instrument Module
Siemens Healthcare Diagnostics Inc.
10282928
In Commercial Distribution

  • 00630414541457 ()
53982-01

  • Nucleic acid sample preparation instrument IVD

ADVIA® Chemistry Calcium Reagents, Concentrated (CA_c)-CPC - 00630414538716

Calcium - ADVIA Chem. - RGT - 4x1450 tests
Siemens Healthcare Diagnostics Inc.
10282576
In Commercial Distribution

  • 00630414538716 ()
6502821

  • Calcium (Ca2+) IVD, kit, spectrophotometry

Hema-Chek® Developer - 00630414538396

For use with the in vitro diagnostic Hema-Chek® Slide Test for the Qualitatitive Determination of Fecal Occult Blood.
Siemens Healthcare Diagnostics Inc.
10313614
In Commercial Distribution

  • 00630414538396 ()
  • 00630414009407 ()
2596

  • Faecal occult blood IVD, kit, rapid colorimetric, clinical

Hema-Chek® Slide Test - 00630414538389

Slide based In vitro diagnostics reagent tests for the Qualitative Determination of Fecal Occult Blood.
Siemens Healthcare Diagnostics Inc.
10313436
In Commercial Distribution

  • 00630414538389 ()
2592

  • Faecal occult blood IVD, kit, rapid colorimetric, clinical

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® TSH3-UL - 00630414535654

TSH - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10282379
In Commercial Distribution

  • 00630414535654 ()
6491080

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

ADVIA Centaur® TSH3-UL - 00630414535647

TSH - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10282378
In Commercial Distribution

  • 00630414535647 ()
6491072

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

ADVIA Centaur® FT4 - 00630414535432

Free T4 (REF) - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10282220
In Commercial Distribution

  • 00630414535432 ()
  • 00630414002927 ()
6490114

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® FT4 - 00630414535425

Free T4 - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10282219
In Commercial Distribution

  • 00630414535425 ()
  • 00630414002910 ()
6490106

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® FT4 - 00630414535418

Free T4 - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10282218
In Commercial Distribution

  • 00630414535418 ()
6490092

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay

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

ADVIA® Chemistry C-Reactive Protein_2 Calibrators - 00630414534244

CRP 2 - ADVIA Chem. - CAL - 6x1mL
Siemens Healthcare Diagnostics Inc.
10337471
In Commercial Distribution

  • 00630414534244 ()
6487741

  • C-reactive protein (CRP) IVD, calibrator

ADVIA® Chemistry Microalbumin_2 Calibrators - 00630414534077

Microalbumin - ADVIA Chem. - CAL - 5x2mL
Siemens Healthcare Diagnostics Inc.
10337470
In Commercial Distribution

  • 00630414534077 ()
6487733

  • Microalbumin IVD, calibrator

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

DCA™ Systems Hemoglobin A1c Reagent Kit - 00630414532806

DCA HbA1c Test Kit (monitoring only) - INTL.
Siemens Healthcare Diagnostics Inc.
10311134
In Commercial Distribution

  • 00630414532806 ()
5035C

  • Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography

DCA™ Systems Microalbumin Creatinine Reagent Kit - 00630414532790

DCA Microablumin Creatinine Test Kit (ACR test).
Siemens Healthcare Diagnostics Inc.
10311480
In Commercial Distribution

  • 00630414532790 ()
6011A

  • Microalbumin IVD, kit, spectrophotometry

ADVIA Centaur® Systems HBeAg QC - 00630414531298

Hepatitis B e Antigen (HBeAg) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10338289
In Commercial Distribution

  • 00630414531298 ()
6981117

  • Hepatitis B virus e-antigen immunoglobulin G (IgG) antibody IVD, control

ADVIA Centaur® VALP MCM - 00630414527369

Valproic Acid Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10322232
Not in Commercial Distribution

  • 00630414527369 ()
5261307

  • Valproic acid therapeutic drug monitoring IVD, control

ADVIA Centaur® Systems Calibrator 28 - 00630414527352

Valproic Acid - CENTAUR - CAL - 6x6x5mL
Siemens Healthcare Diagnostics Inc.
10322227
Not in Commercial Distribution

  • 00630414527352 ()
5260521

  • Valproic acid therapeutic drug monitoring IVD, calibrator

ADVIA Centaur® Systems, ACS:180® Systems Calibrator 28 - 00630414527345

Valproic Acid - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10322222
Not in Commercial Distribution

  • 00630414527345 ()
5259132

  • Valproic acid therapeutic drug monitoring IVD, calibrator

ADVIA Centaur® VALP +28 - 00630414527338

Valproic Acid - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10322218
Not in Commercial Distribution

  • 00630414527338 ()
  • 00630414027647 ()
5258292

  • Valproic acid therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® VALP +28 - 00630414527321

Valproic Acid - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10322215
Not in Commercial Distribution

  • 00630414527321 ()
5256877

  • Valproic acid therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® Gentamicin MCM - 00630414527307

Gentamicin Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10322163
Not in Commercial Distribution

  • 00630414527307 ()
5227559

  • Gentamicin therapeutic drug monitoring IVD, control

ADVIA Centaur® Systems Gentamicin Calibrator - 00630414527291

Gentamicin - CENTAUR - CAL - 6x6x2mL
Siemens Healthcare Diagnostics Inc.
10322161
Not in Commercial Distribution

  • 00630414527291 ()
5226870

  • Gentamicin therapeutic drug monitoring IVD, calibrator

ADVIA Centaur® Systems, ACS:180® Systems GENT Calibrator - 00630414527284

Gentamicin - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10322159
Not in Commercial Distribution

  • 00630414527284 ()
5226110

  • Gentamicin therapeutic drug monitoring IVD, calibrator
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