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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5 Pan w/COC/THC/AMP/BZO/BAR pack Bulk
AMERICAN BIO MEDICA CORPORATION
10-5SPB-139
In Commercial Distribution

  • 10694644300403 ()
  • 10694644350408 ()
10-5SPB-139

  • 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
5 Panel Drug Test Cup AMP/COC/OPI/THC/PCP
UCP BIOSCIENCES, INC.
U-CUP-154
In Commercial Distribution

  • 20817038022287 ()
  • 10817038022280 ()
  • 00817038022283 ()
U-CUP-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Drug Test Cup AMP/COC/OPI/PCP/THC
UCP BIOSCIENCES, INC.
U-CUP-154
In Commercial Distribution

  • 20817038021273 ()
  • 10817038021276 ()
  • 00817038021279 ()
U-CUP-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 panel Test Card AMP/BZO/COC/MET/OPI/THC
UCP BIOSCIENCES, INC.
U-DOA-264L
In Commercial Distribution

  • 20817038021150 ()
  • 10817038021153 ()
  • 00817038021156 ()
U-DOA-264L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Drug Test Cup AMP/COC/MET/OPI/THC
UCP BIOSCIENCES, INC.
U-CUP-254
In Commercial Distribution

  • 20817038021112 ()
  • 10817038021115 ()
  • 00817038021118 ()
U-CUP-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Drug Test Card COC/OPI/MTD/BZO/OXY/THC
UCP BIOSCIENCES, INC.
UCD-6-1-CLIA
In Commercial Distribution

  • 20817038020788 ()
  • 10817038020781 ()
  • 00817038020784 ()
UCD-6-1-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Drug Test Cup COC/THC/MET/OPI/ PCP/AMP
UCP BIOSCIENCES, INC.
U-CUP-264-RCLN
In Commercial Distribution

  • 20817038020696 ()
  • 10817038020699 ()
  • 00817038020692 ()
U-CUP-264-RCLN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 08 COC/THC/OPI300/AMP/MAMP/PCP/BZO/OXY
REDWOOD TOXICOLOGY LABORATORY, INC.
011020179
In Commercial Distribution

  • 10858904006362 ()
  • 00858904006365 ()
DOA-184-521

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Panel 08 COC/ THC/AMP/MAMP/OPI2/MDMA/OXY/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020169
In Commercial Distribution

  • 10858904006300 ()
  • 00858904006303 ()
DOA-184-471

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Drug Screening Test Cup BUP/BZO/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP5-BUP
In Commercial Distribution

  • 20850721007178 ()
  • 10850721007171 ()
  • 00850721007174 ()
ID-CP5-BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Drug Test Card AMP/COC/THC/MET/MOP
MEDICAL DISTRIBUTION GROUP INC
ID-CP5-DIP
In Commercial Distribution

  • 20850721007376 ()
  • 10850721007379 ()
  • 00850721007372 ()
ID-CP5-DIP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Drug Screening Test Cup BUP/BZO/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP5-BUP
In Commercial Distribution

  • 20850721007321 ()
  • 10850721007324 ()
  • 00850721007327 ()
ID-CP5-BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Drug Screening Test Cup THC/OXY/MOP/BZO/COC
MEDICAL DISTRIBUTION GROUP INC
ID-CP5
In Commercial Distribution

  • 20850721007161 ()
  • 10850721007164 ()
  • 00850721007167 ()
ID-CP5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, COC, OPI, PCP, THC
BIO-RAD LABORATORIES, INC.
194-5200
In Commercial Distribution

  • 00847817000591 ()
1945200

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, BZO, COC, OPI, THC
BIO-RAD LABORATORIES, INC.
194-5216
In Commercial Distribution

  • 00847817000379 ()
1945216

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 4 THC / OPI / COC/ mAMP
Siemens Healthcare Diagnostics Inc.
10445364
In Commercial Distribution

  • 00842768001352 ()
  • 00630414013985 ()
6A339UL

  • 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
BUP10/BZO300/COC150/MOR300/OPI2000/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA07141 ()
  • B115ABCUPA07140 ()
ABCupA-07-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BUP10/COC150/MET500/MOR300/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA07091 ()
  • B115ABCUPA07090 ()
ABCupA-07-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/MET500/OPI2000/PCP/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA07071 ()
  • B115ABCUPA07070 ()
ABCupA-07-07

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/MET500/OPI2000/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA07061 ()
  • B115ABCUPA07060 ()
ABCupA-07-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BUP/BZO/COC/MDMA/MOR/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA07041 ()
  • B115ABCUPA07040 ()
ABCupA-07-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BZO/COC/MET/MOR/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA07031 ()
  • B115ABCUPA07030 ()
ABCupA-07-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BUP10/BZO300/COC150/MDMA/MET500/MOR300/MTD/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP10201 ()
  • B115ABCUP10200 ()
ABCup-10-20

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BZO300/COC150/MDMA/MET500/MOR300/MTD/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP10191 ()
  • B115ABCUP10190 ()
ABCup-10-19

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BZO300/COC150/MET500/MOR300/MTD/OXY /PCP/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP10161 ()
  • B115ABCUP10160 ()
ABCup-10-16

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
(AMP500/OPI2000)+(COC/THC)+(MET/PCP)+BAR300+BZO300+MTD+PPX
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP10101 ()
  • B115ABCUP10100 ()
ABCup-10-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BUP10/BZO300/COC150/MET500/MOR300/MTD/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP10091 ()
  • B115ABCUP10090 ()
ABCup-10-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/PPX/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP10061 ()
  • B115ABCUP10060 ()
ABCup-10-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BUP10/BZO300/COC150/MOR300/OPI2000/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA07141 ()
  • B115ABCARDA07140 ()
ABCardA-07-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BUP10/COC150/MET500/MOR300/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA07091 ()
  • B115ABCARDA07090 ()
ABCardA-07-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/MET500/OPI2000/PCP/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA07071 ()
  • B115ABCARDA07070 ()
ABCardA-07-07

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/MET500/OPI2000/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA07061 ()
  • B115ABCARDA07060 ()
ABCardA-07-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BUP/BZO/COC/MDMA/MOR/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA07041 ()
  • B115ABCARDA07040 ()
ABCardA-07-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BZO/COC/MET/MOR/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA07031 ()
  • B115ABCARDA07030 ()
ABCardA-07-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BUP10/BZO300/COC150/MDMA/MET500/MOR300/MTD/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD10201 ()
  • B115ABCARD10200 ()
ABCard-10-20

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BZO300/COC150/MDMA/MET500/MOR300/MTD/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD10191 ()
  • B115ABCARD10190 ()
ABCard-10-19

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BZO300/COC150/MET500/MOR300/MTD/OXY /PCP/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD10161 ()
  • B115ABCARD10160 ()
ABCard-10-16

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
(AMP500/OPI2000)+(COC/THC)+(MET/PCP)+BAR300+BZO300+MTD+PPX
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD10101 ()
  • B115ABCARD10100 ()
ABCard-10-10

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