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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Nonin Compatible Reusable SpO2 Sensor, Adult Finger
APK Technology Co.,Ltd.
A1414-SA103PV
In Commercial Distribution

  • 06946725538036 ()


  • Pulse Co-oximeter probe, reusable
Nonin Compatible Reusable SpO2 Sensor, Adult Soft Tip
APK Technology Co.,Ltd.
A1414-SA103PU
In Commercial Distribution

  • 06946725538029 ()


  • Pulse Co-oximeter probe, reusable
Incup with THC/COC/OPI300/METH/BAR/MDMA/SVT
AMERICAN BIO MEDICA CORPORATION
10-6SPCA-308
In Commercial Distribution

  • 10694644400714 ()
  • 10694644450719 ()
10-6SPCA-308

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
10X w/BUP/OXY NO PCP,PPX Op3 +SVT
AMERICAN BIO MEDICA CORPORATION
10-10BPXTA-030
In Commercial Distribution

  • 10694644100423 ()
  • 10694644150428 ()
10-10BPXTA-030

  • Buprenorphine IVD, calibrator
10XX2 PLUS BUP, OXY AND SVT pack in Bulk
AMERICAN BIO MEDICA CORPORATION
10-10SPX2AB-339
In Commercial Distribution

  • 10694644200291 ()
  • 10694644250296 ()
10-10SPX2AB-339

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
5 Rap Tox Cup w/PCP opi 2 SVT
AMERICAN BIO MEDICA CORPORATION
10-5PX2A-200
In Commercial Distribution

  • 10694644200031 ()
  • 10694644250036 ()
10-5PX2A-200

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RTCII with THC/COC/METH/OPI300/BAR/BZO/MDMA/SVT
AMERICAN BIO MEDICA CORPORATION
10-7MX2A-030
In Commercial Distribution

  • 10694644200451 ()
  • 10694644250456 ()
10-7MX2A-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RTCII with THC/COC/METH/OPI300/AMP/BAR/BZO/MDMA/SVT
AMERICAN BIO MEDICA CORPORATION
10-8MZX2A-030
In Commercial Distribution

  • 10694644200468 ()
  • 10694644250463 ()
10-8MZX2A-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
12 Panel CLIA Waived Click Cup w/ SVT AMP500, BAR300, BUP10, BZO300, COC150, MDMA500, MET500, MOP300, MTD300, OXY100, PCP25, THC50 w/ SVT OX/SG/pH
Instant Technologies, Inc.
ABTDUAW112706F
In Commercial Distribution

  • 30817405023838 ()
  • 00817405023837 ()
  • 10817405023834 ()
ABTDUAW112706F

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel CLIA Waived Flat Cup w/ SVT AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, THC50 w/ SVT CR/SG/Ph
Instant Technologies, Inc.
ABTDUAW112705E
In Commercial Distribution

  • 30817405023814 ()
  • 00817405023813 ()
  • 10817405023810 ()
ABTDUAW112705E

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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