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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 Class Implantable

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ADVIA® Chemistry XTC Ecstasy Reagents - 00630414569857

Ecstasy - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378735
Not in Commercial Distribution

  • 00630414569857 ()
10378735

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry AMPH_2 Amphetamines_2 Reagents - 00630414568744

Amphetamines - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378758
Not in Commercial Distribution

  • 00630414568744 ()
10378758

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)

Azostix® Reagent Strips - 00630414551142

AZOSTIX® is a firm, plastic strip to which is affixed an impregnated reagent area for estimating the amount of urea nitrogen in whole blood to provide information on renal function.
Siemens Healthcare Diagnostics Inc.
10324060
In Commercial Distribution

  • 00630414551142 ()
  • 00630414009544 ()
A2830C16

  • Urea IVD, kit, enzyme spectrophotometry

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

ADVIA® Chemistry ACET Acetaminophen Reagents - 00630414498942

Acetaminophen - ADVIA Chem. - RGT - 4x150 tests
Siemens Healthcare Diagnostics Inc.
10327381
In Commercial Distribution

  • 00630414498942 ()
7989138

  • Acetaminophen IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry CO2_L Reagents (Liquid) - 00630414498928

CO2 enzymatic - ADVIA Chem. - RGT - 4x600 tests
Siemens Healthcare Diagnostics Inc.
10327377
Not in Commercial Distribution

  • 00630414498928 ()
  • 00630414003634 ()
7987100

  • Carbon dioxide (CO2) IVD, kit, spectrophotometry

ADVIA Centaur® FOL (25-pack) - 00630414469454

TBD
Siemens Healthcare Diagnostics Inc.
10340209
In Commercial Distribution

  • 00630414469454 ()
131096

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
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