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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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Urisys 2400 Calibration strip - 04015630004683

No Description
Roche Diagnostics GmbH
3012590061
In Commercial Distribution

  • 04015630004683 ()
3012590061

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Urisys 2400 Cassette - 04015630004652

No Description
Roche Diagnostics GmbH
3012557061
In Commercial Distribution

  • 04015630004652 ()
3012557061

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

Hemastix® Reagent Strips - 00630414550596

HEMASTIX® is a firm plastic strip to which is affixed a reagent area that tests for occult blood in urine. Test results may provide information on urinary tract status.
Siemens Healthcare Diagnostics Inc.
10312568
In Commercial Distribution

  • 00630414550596 ()
  • 00630414009353 ()
A2190B16

  • Urine blood 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

NA - 00848838023835

No Description
REMEL, INC.
R21526
In Commercial Distribution

  • 00848838023835 ()
  • 00848838099847 ()


  • Aniline blue solution IVD

Urine Reagent Strips, 1-parameter, blood - 00664816000076

Urine reagent strips; 1-parameter; blood; 100 strips per vial
LW SCIENTIFIC, INC.
URS-01PR-BL77
In Commercial Distribution

  • 00664816000076 ()


  • Urine blood IVD, kit, rapid colorimetric, clinical

Mission Urinalysis Reagent Strips - 00682607200061

Mission Urinalysis Reagent Strips (BLO)
ACON LABORATORIES, INC.
U031-011
In Commercial Distribution

  • 20682607200065 ()
  • 00682607200061 ()
  • 00682607000692 ()


  • Urine blood IVD, kit, rapid colorimetric, clinical

Mission Urinalysis Reagent Strips - 00682607000333

Mission Urinalysis Reagent Strips (BLO)
ACON LABORATORIES, INC.
U031-011
In Commercial Distribution

  • 00682607000333 ()
  • 00682607000692 ()


  • Urine blood IVD, kit, rapid colorimetric, clinical

TECO DIAGNOSTICS - 10673486000146

URS-1B-100 GENERIC
TECO DIAGNOSTICS
URS-1B-100 GENERIC
In Commercial Distribution

  • 10673486000146 ()
URS-1B-100G

  • Urine blood IVD, kit, rapid colorimetric, clinical

TECO DIAGNOSTICS - 10673486000139

URS-1B-100 BOTTLE ONLY
TECO DIAGNOSTICS
URS-1B-100 BOTTLE
In Commercial Distribution

  • 10673486000139 ()
URS-1B-100B

  • Urine blood IVD, kit, rapid colorimetric, clinical
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