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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For the cannulation of B-D Vacutainer® 4 or 5 mL lithium heparin collection tubes, with HEMOGARD® closure, to be used on the Stratus® CS STAT Fluorometric Analyzer.
Siemens Healthcare Diagnostics Inc.
10445063
In Commercial Distribution

  • 00842768004438 ()
  • 00630414009780 ()
CCANBD

  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated
The Stratus® CS Acute Care™ Beta human Chorionic Gonadotropin Dilution Pak (ßhCG DilPak), in vitro diagnostic product intended to be used in conjunction with the Acute Care™ ßhCG TestPak on the Stratus® CS analyzer for the measurement of samples with elevated ßhCG levels.
Siemens Healthcare Diagnostics Inc.
10445062
In Commercial Distribution

  • 00842768004421 ()
  • 00630414009773 ()
CBHCG-D

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay
The Status® CS Acute Care(TM) Beta human Chorionic Gonadotropin CalPak calibrator (ßhCG CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care(TM) ßhCG method.
Siemens Healthcare Diagnostics Inc.
10445061
In Commercial Distribution

  • 00842768004414 ()
  • 00630414009766 ()
CBHCG-C

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay
The Stratus® CS Acute Care™ Beta human Chorionic Gonadotropin method (ßhCG) is an in vitro diagnostic test for the quantitative measurement of the total beta subunit, vis, both the intact hCG dimer and the free ß subunit, of the human chorionic gonadotropin hormone in heparinized plasma.
Siemens Healthcare Diagnostics Inc.
10445060
In Commercial Distribution

  • 00842768004407 ()
  • 00630414009759 ()
CBHCG

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay
Syva® RapidTest d.a.u.® 10 mAMP/OPI/COC/THC/PCP/BZO/BAR/MDN/TCA/AMP
Siemens Healthcare Diagnostics Inc.
10445363
In Commercial Distribution

  • 00842768001345 ()
  • 00630414013978 ()
6A289UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 9 mAMP / OPI / COC / THC / PCP / BZO / BAR / TCA / AMP
Siemens Healthcare Diagnostics Inc.
10445362
Not in Commercial Distribution

  • 00842768001338 ()
  • 00630414013961 ()
6A279UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 8 THC / OPI / COC / mAMP / BZO / BAR / TCA / PCP
Siemens Healthcare Diagnostics Inc.
10445361
Not in Commercial Distribution

  • 00842768001321 ()
  • 00630414013954 ()
6A269UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 5 mAMP / OPI / COC / THC / PCP
Siemens Healthcare Diagnostics Inc.
10445360
In Commercial Distribution

  • 00842768001314 ()
  • 00630414013947 ()
6A259UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 4 THC / OPI / COC / AMP
Siemens Healthcare Diagnostics Inc.
10445359
In Commercial Distribution

  • 00842768001307 ()
  • 00630414013923 ()
6A199UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 3 THC / COC / OPI
Siemens Healthcare Diagnostics Inc.
10445358
In Commercial Distribution

  • 00842768001291 ()
  • 00630414013916 ()
6A179UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest™ Tricyclic Antidepressants TCA
Siemens Healthcare Diagnostics Inc.
10445355
In Commercial Distribution

  • 00842768001277 ()
  • 00630414013879 ()
6A119UL

  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® Methadone MDN
Siemens Healthcare Diagnostics Inc.
10445354
In Commercial Distribution

  • 00842768001260 ()
  • 00630414013862 ()
6A109UL

  • Methadone IVD, kit, rapid ICT, clinical
Syva® Emit® Antiepileptic Drug Calibrators
Siemens Healthcare Diagnostics Inc.
10445353
In Commercial Distribution

  • 00842768001253 ()
6A089UL

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator
Syva® RapidTest d.a.u.® Barbiturates BAR
Siemens Healthcare Diagnostics Inc.
10445352
In Commercial Distribution

  • 00842768001246 ()
  • 00630414013855 ()
6A079UL

  • Barbiturate IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® Amphetamines AMP
Siemens Healthcare Diagnostics Inc.
10445350
In Commercial Distribution

  • 00842768001222 ()
  • 00630414013831 ()
6A059UL

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® Opiates OPI
Siemens Healthcare Diagnostics Inc.
10445349
In Commercial Distribution

  • 00842768001215 ()
  • 00630414013824 ()
6A049UL

  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® Methamphetamine mAMP
Siemens Healthcare Diagnostics Inc.
10445348
In Commercial Distribution

  • 00842768001208 ()
  • 00630414013817 ()
6A039UL

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® Cannabinoids THC
Siemens Healthcare Diagnostics Inc.
10445347
In Commercial Distribution

  • 00842768001192 ()
  • 00630414013800 ()
6A029UL

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® Cocaine COC
Siemens Healthcare Diagnostics Inc.
10445346
In Commercial Distribution

  • 00842768001185 ()
  • 00630414013794 ()
6A019UL

  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
Syva® Emit® 2000 Vancomycin Calibrators
Siemens Healthcare Diagnostics Inc.
10445337
In Commercial Distribution

  • 00842768001116 ()
4W109UL

  • Vancomycin therapeutic drug monitoring IVD, calibrator
Syva® Emit® 2000 Vancomycin Assay
Siemens Healthcare Diagnostics Inc.
10445336
In Commercial Distribution

  • 00842768001109 ()
4W019UL

  • Vancomycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Emit ® 2000 Gentamicin Plus Calibrators
Siemens Healthcare Diagnostics Inc.
10445334
In Commercial Distribution

  • 00842768001093 ()
4T209UL

  • Gentamicin therapeutic drug monitoring IVD, calibrator
Emit ® 2000 Gentamicin Plus Assay
Siemens Healthcare Diagnostics Inc.
10445333
In Commercial Distribution

  • 00842768001086 ()
4T039UL

  • Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® 2000 Tobramycin Calibrators
Siemens Healthcare Diagnostics Inc.
10445331
In Commercial Distribution

  • 00842768001079 ()
4S109UL

  • Tobramycin therapeutic drug monitoring IVD, calibrator
Syva® Emit® 2000 Tobramycin Assay
Siemens Healthcare Diagnostics Inc.
10445330
In Commercial Distribution

  • 00842768001062 ()
4S019UL

  • Tobramycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® 2000 Quinidine Calibrators
Siemens Healthcare Diagnostics Inc.
10445328
In Commercial Distribution

  • 00842768001055 ()
4Q109UL

  • Quinidine therapeutic drug monitoring IVD, calibrator
Syva® Emit® 2000 Qunidine Assay
Siemens Healthcare Diagnostics Inc.
10445327
In Commercial Distribution

  • 00842768001048 ()
4Q019UL

  • Quinidine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® 2000 Theophylline Calibrators
Siemens Healthcare Diagnostics Inc.
10445325
In Commercial Distribution

  • 00842768001031 ()
4P109UL

  • Theophylline therapeutic drug monitoring IVD, calibrator
Syva® Emit® 2000 Theophylline Assay
Siemens Healthcare Diagnostics Inc.
10445324
In Commercial Distribution

  • 00842768001024 ()
4P019UL

  • Theophylline therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Emit ® 2000 N-Acetylprocainamide Calibrators
Siemens Healthcare Diagnostics Inc.
10445322
In Commercial Distribution

  • 00842768001017 ()
4N109UL

  • N-acetyl procainamide (NAPA) IVD, calibrator
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