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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® 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
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