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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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Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / M-AMP / OPI / THC / CRE
LUMIQUICK DIAGNOSTICS, INC.
07RD7113-04
In Commercial Distribution

  • M90107RD7113040 ()

  • Length: 74 Millimeter
07RD7113-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / COC / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7113-03
In Commercial Distribution

  • M90107RD7113030 ()

  • Length: 74 Millimeter
07RD7113-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7113-02
In Commercial Distribution

  • M90107RD7113020 ()

  • Length: 74 Millimeter
07RD7113-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / M-AMP/ MTD / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-19
In Commercial Distribution

  • M90107RD7070191 ()
  • M90107RD7070190 ()

  • Length: 75 Millimeter
07RD7070-19

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-AMP / MTD / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-17
In Commercial Distribution

  • M90107RD7070171 ()
  • M90107RD7070170 ()

  • Length: 75 Millimeter
07RD7070-17

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-15
In Commercial Distribution

  • M90107RD7070151 ()
  • M90107RD7070150 ()

  • Length: 75 Millimeter
07RD7070-15

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-14
In Commercial Distribution

  • M90107RD7070141 ()
  • M90107RD7070140 ()

  • Length: 75 Millimeter
07RD7070-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-13
In Commercial Distribution

  • M90107RD7070131 ()
  • M90107RD7070130 ()

  • Length: 75 Millimeter
07RD7070-13

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-12
In Commercial Distribution

  • M90107RD7070121 ()
  • M90107RD7070120 ()

  • Length: 75 Millimeter
07RD7070-12

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-11
In Commercial Distribution

  • M90107RD7070111 ()
  • M90107RD7070110 ()

  • Length: 75 Millimeter
07RD7070-11

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / MTD / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-04
In Commercial Distribution

  • M90107RD7070041 ()
  • M90107RD7070040 ()

  • Length: 75 Millimeter
07RD7070-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7070-14
In Commercial Distribution

  • 00817830022795 ()

  • Length: 75 Millimeter
07RD-7070-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / M-AMP / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7070-15
In Commercial Distribution

  • 00817830022665 ()

  • Length: 75 Millimeter
07RD-7070-15

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / MTD / OPI-II/ THC
RAPID DIAGNOSTICS INC
07RD7070-05A
In Commercial Distribution

  • 00817830022047 ()

  • Length: 75 Millimeter
07RD7070-05A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7070-04
In Commercial Distribution

  • 00817830022016 ()

  • Length: 75 Millimeter
07RD7070-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / BUP / COC / M-AMP / OPI / THC
RAPID DIAGNOSTICS INC
07RD7070-03
In Commercial Distribution

  • 00817830021996 ()

  • Length: 75 Millimeter
07RD7070-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / M-AMP / OPI / PCP / THC
RAPID DIAGNOSTICS INC
07RD7070-01
In Commercial Distribution

  • 00817830021958 ()

  • Length: 75 Millimeter
07RD7070-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 Tests/Kit;12 Panel;AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC,CR,PH,SG
Eterbio, Inc.
ETG011025
In Commercial Distribution

  • 06977469280189 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 Tests/Kit;12 Panel;AMP;BAR;BUP;BZO;COC;MDMA;MET;MOP;MTD;OXY;PCP;THC;CR;PH;SG
Eterbio, Inc.
ETG004025
In Commercial Distribution

  • 06977469280042 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QuikScreen Multi 7 Drug Cup Test - AMP 500, MDMA 500, COC 300, MET 500, OPI 300, MAD 300, THC 50
SYNTRON BIORESEARCH, INC.
60719
In Commercial Distribution

  • 20748349000131 ()
  • 10748349000134 ()
  • 00748349000137 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
QUIKSCREEN MULTI 6+1 DRUG CUP TEST - AMP 1000, BZD 300, COC 300, MET 1000, OPI 300, THC 50 + ALC
SYNTRON BIORESEARCH, INC.
65646-19
In Commercial Distribution

  • 20748349000292 ()
  • 10748349000295 ()
  • 00748349000298 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
UDOA-12CE-0712-01 (Ox/Cr/pH)+<BUP>+(OXY/PPX)+(mAMP/MOP/PCP)+(BZO/MTD/BAR)+(AMP/COC/THC)MULTI-DRUG previous (GTIN 10869419000233)
Quest Diagnostics
UDOA-12CE-0712-01
In Commercial Distribution

  • 00869419000236 ()
  • 30869419000237 ()
DUE-1127-051-19-ONW504A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Integrated Split Specimen Cups (COC/AMP/MET/THC/MTD/MDMA/MOP/OXY/PPX/BAR/BZO/BUP) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, 3,4-Methylenedioxy-Methamphetamine, Morphine, Oxycodone, Propoxyphene, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine and THC metabolites in urine.
BTNX Inc
D12.1-1G29-25
In Commercial Distribution

  • 00722066003701 ()
  • 00722066004159 ()
D12.1-1G29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug One Step Cup (AMP/BAR/BUP/BZO/COC/MDMA/MTD/MET/OPI/OXY/THC/PCP) - 25 Tests/ kit are for the qualitative detection of Amphetamine, Barbiturate, Buprenorphine, Bezodiazepines, 3,4-Methylenedioxy-Methamphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Phencyclidine, Cocaine and THC metabolites in urine.
BTNX Inc
D12.5-1T
In Commercial Distribution

  • 00722066003695 ()
  • 00722066004098 ()
D12.5-1T

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Twelve Panel Clear Scan Drug Test Cup Drug Combo: AMP | BAR | BUP | BZO | COC | MDMA | MET | MOR | MTD | OXY | PCP | THC
MERGERS MARKETING, INC.
CSC-6125
In Commercial Distribution

  • 00850557007966 ()
  • 00850557007973 ()
  • 10850557007970 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Twelve Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BUP | BZO | COC | MDMA | MET | MOR | MTD | OXY | PCP | THC
MERGERS MARKETING, INC.
PSC-DOA-6125
In Commercial Distribution

  • 00850557007683 ()
  • 00850557007690 ()
  • 10850557007697 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Twelve Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo:AMP | BAR | BZO | COC | MDMA | MET | MOR | MTD | OXY | PCP | TCA | THC
MERGERS MARKETING, INC.
PS-DOA-7125
In Commercial Distribution

  • 00850557007249 ()
  • 00850557007256 ()
  • 10850557007253 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Eleven Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BAR| BZO| COC | MDMA | MET | OPI | MTD | PPX | PCP | THC
MERGERS MARKETING, INC.
PS-DOA-1114
In Commercial Distribution

  • 00850557007065 ()
  • 00850557007072 ()
  • 10850557007079 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MET | MTD | OPI | OXY | PCP | THC With Alcohol
MERGERS MARKETING, INC.
PSC-DOA-4104A
In Commercial Distribution

  • 10851000007073 ()
  • 00851000007076 ()
  • 00851000007069 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Twelve Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MDMA | MET | MOP | MTD | OXY | PCP| TCA | THC
MERGERS MARKETING, INC.
PSC-DOA-7125
In Commercial Distribution

  • 00851000007120 ()
  • 10851000007127 ()
  • 20851000007124 ()


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