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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® Chemistry TOX NEG Calibrator - 00630414551043

Serum Tox Neg ibrator - ADVIA Chem. - CAL - 1x10mL
Siemens Healthcare Diagnostics Inc.
10283015
Not in Commercial Distribution

  • 00630414551043 ()
6520226

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator

ADVIA® Chemistry TCA - 00630414551036

Tricyclic Antidepressants - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10283014
Not in Commercial Distribution

  • 00630414551036 ()
6520218

  • Tricyclic antidepressant IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry METMTB Calibrator - Urine - 00630414550954

Methadone Metabolic - ADVIA Chem. - CAL - 1x10mL
Siemens Healthcare Diagnostics Inc.
10283006
Not in Commercial Distribution

  • 00630414550954 ()
6520080

  • 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator

ADVIA® Chemistry Multi-Drug Urine Controls 1,2 - 00630414550916

Multi-Drug Urine Kit - ADVIA Chem. - CONS - 3x2x5mL
Siemens Healthcare Diagnostics Inc.
10282987
Not in Commercial Distribution

  • 00630414550916 ()
6520064

  • Multiple therapeutic drugs/drugs of abuse IVD, control

Albustix® Reagent Strips - 00630414550602

ALBUSTIX® are intended for in vitro diagnostic use by healthcare professionals to detect the presence of protein in urine.
Siemens Healthcare Diagnostics Inc.
10333485
In Commercial Distribution

  • 00630414550602 ()
  • 00630414009650 ()
A2191B16

  • Urine protein 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

Multistix PRO® 10LS Reagent Strips - 00630414549262

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.
10332782
In Commercial Distribution

  • 00630414549262 ()
  • 00630414009643 ()
A1566C16

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

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
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