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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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
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
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
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
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
5 PANEL CLIA WAIVED SQUARE CUP AMP500, BZO300, COC150, MET500, MOP300 SVT (CR,pH,S.G.)
Instant Technologies, Inc.
ABTDUAW15702B
In Commercial Distribution

  • 30817405023395 ()
  • 00817405023394 ()
  • 10817405023391 ()
ABTDUAW15702B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
RTCII 1ST GEN THC/COC/METH/OPI300/AMP/BZO/ OXY/BAR/MTD/PCP/PPX/SVT
AMERICAN BIO MEDICA CORPORATION
10-11SPX2A-516
In Commercial Distribution

  • 10694644200482 ()
  • 10694644250487 ()
10-11SPX2A-516

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
PANEL 12 COC/THC/OPI300/AMP/MAMP/PCP/BZO/BAR/MTD/MDMA/OXY/BUP WITH SVT ???
REDWOOD TOXICOLOGY LABORATORY, INC.
011020188
In Commercial Distribution

  • 10858904006430 ()
  • 00858904006433 ()
DOA-1124-081

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 PANEL CLIA WAIVED SQUARE CUP AMP1000, BZO300, COC300, MOP300, OXY100, THC50 SVT (CR,OX,S.G.)
Instant Technologies, Inc.
ABTDUAW16701A
In Commercial Distribution

  • 30817405023258 ()
  • 00817405023257 ()
  • 10817405023254 ()
ABTDUAW16701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iCUP Rx 5 Drug w/SVT (pH, SG, OX, CR,NI) (BZO300/BUP10/MTD300/OPI300/OXY100)
Instant Technologies, Inc.
I-RXA-157-01
In Commercial Distribution

  • 00817405020270 ()
I-RXA-157-01

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