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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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
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
14 Panel CLIA Waived Click Cup w/ SVT AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000, OXY100, PCP25, PPX300, TCA1000, THC50 w/ SVT OX/SG/pH
Instant Technologies, Inc.
ABTDUAW114704D
In Commercial Distribution

  • 30817405023883 ()
  • 00817405023882 ()
  • 10817405023889 ()
ABTDUAW114704D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14 Panel CLIA Waived Click Cup w/ SVT AMP1000, BAR300, BUP10, BZO300, COC300, EDDP300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, TCA1000, THC50 w/ SVT OX/SG/Ph
Instant Technologies, Inc.
ABTDUAW114703C
In Commercial Distribution

  • 30817405023845 ()
  • 00817405023844 ()
  • 10817405023841 ()
ABTDUAW114703C

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Drug MINICUP THC/COC150/METH500/OPI300/BAR/BZO/PCP/AMP500/SVT
AMERICAN BIO MEDICA CORPORATION
10-8MBZ3A-030
In Commercial Distribution

  • 10694644500407 ()
  • 10694644550402 ()
10-8MBZ3A-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
7 DRUG MINICUP COC150/METH500/OPI300 AMP500/PCP/BAR/BZO and SVT
AMERICAN BIO MEDICA CORPORATION
10-7MBZ3A-030
In Commercial Distribution

  • 10694644500353 ()
  • 10694644550358 ()
10-7MBZ3A-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
7 DRUG MINICUP COC150/METH500/OPI300 AMP500/PCP/BAR/BZO and SVT
AMERICAN BIO MEDICA CORPORATION
10-7MBZ3A-030
Not in Commercial Distribution

  • 10694644500254 ()
  • 10694644550259 ()
10-7MBZ3A-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RTC II cup with SVT/AMP/BZO/THC/COC/METH/OPI/BAR/MDMA in Bulk RTC II 1st Generation with SVT/AMP/BZO/THC/COC/METH/OPI/BAR/MDMA
AMERICAN BIO MEDICA CORPORATION
10-8MZX2AB-030
In Commercial Distribution

  • 10694644200475 ()
  • 10694644250470 ()
10-8MZX2AB-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
T-Cup with Vaccu Lid,3 SVT strips (CR/pH/S.G.) and Temp Strip
WONDFO USA CO., LTD.
TDOA-SVTV
In Commercial Distribution

  • 10816862024262 ()
  • 00816862024265 ()
  • 00816862024272 ()


  • General specimen container IVD, additive/medium
5 PANEL 510(K) SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50 SVT (CR,OX,SG)
Instant Technologies, Inc.
ABTDUAK15701A
In Commercial Distribution

  • 30817405023500 ()
  • 00817405023509 ()
  • 10817405023506 ()
ABTDUAK15701A

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